HPLC is the dominant separation technique in modern pharmaceutical and biomedical analysis because it results in highly efficient separations and in most cases provides high detection sensitivity. Most of the drugs in multi component dosage forms can be analyzed by HPLC method because of the several advantages like rapidity, specificity, accuracy, precision and ease of automation in this method. HPLC methods development and validation plays an important role in new discovery, development, manufacture of pharmaceutical drugs and various other studies related to humans and animals. This review gives information regarding various stages involved in development and validation of HPLC method. Validation of HPLC method as per ICH Guidelines covers all the performance characteristics of validation, like Accuracy, Precision, Specificity, Linearity, Range and Limit of detection, Limit of quantification, Robustness and system suitability testing. Tanmayi Kalamkar | Tejaswini Kande | Naziya Sayyad | Dipti Patil "Analytical Method Development by High Performance Liquid Chromatography" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-4 , June 2022, URL: https://www.ijtsrd.com/papers/ijtsrd50177.pdf Paper URL: https://www.ijtsrd.com/pharmacy/analytical-chemistry/50177/analytical-method-development-by-high-performance-liquid-chromatography/tanmayi-kalamkar
Analytical method development and validation for simultaneous estimationProfessor Beubenz
Brief about analytical method development and validation
Subscribe to the YouTube Channel #Professor_Beubenz
https://www.youtube.com/channel/UC84jGf2iRN5VjwnQqi6qmXg?view_as=subscriber
What is COPPs? How to apply for COPPs (Certificate of Pharmaceutical Products)?Ajay kamboj
CoPP is necessary for exporting medicines and pharmaceutical products from India. The application for grant of WHO GMP Certificate of Pharmaceutical Product shall be made to respective zonal/sub zonal officers appointed by DCGI as per the requirement.
Analytical method development and validation for simultaneous estimationProfessor Beubenz
Brief about analytical method development and validation
Subscribe to the YouTube Channel #Professor_Beubenz
https://www.youtube.com/channel/UC84jGf2iRN5VjwnQqi6qmXg?view_as=subscriber
What is COPPs? How to apply for COPPs (Certificate of Pharmaceutical Products)?Ajay kamboj
CoPP is necessary for exporting medicines and pharmaceutical products from India. The application for grant of WHO GMP Certificate of Pharmaceutical Product shall be made to respective zonal/sub zonal officers appointed by DCGI as per the requirement.
CALIBRATION OF HPLC
Pressure Test.
Drift and Noise
Column oven and sample cooler
Pump by flow rate accuracy measurement.
Pump by gradient flow measurement.
UV-Vis / PDA detector by reference energy check.
The drug or drug combination may not be official in any pharmacopoeias.
A proper analytical procedure for the drug may not be available in the literature due to patent regulations.
Analytical methods may not be available for the drug in the form of a formulation due to the interference caused by the formulation excipients.
Analytical methods for the quantitation of the drug in biological fluids may not be available.
Analytical methods for a drug in combination with other drugs may not be available.
The existing analytical procedures may require expensive reagents and solvents. It may also involve cumbersome extraction and separation procedures and these may not be reliable.
Stability Indicating HPLC Method Development A Reviewijtsrd
High performance liquid chromatography HPLC is an essential analytical tool for evaluating drug stability. HPLC methods must be able to isolate, detect, and quantify drug related degradation products that may form during storage or production, and identify drug related impurities that may form during synthesis. .. This article describes strategies and challenges for designing HPLC methods to demonstrate drug stability. It will deepen our understanding of drugs and medicinal chemistry and demonstrate advances in stability that reflect an analytical approach. Several important chromatographic parameters were investigated to improve the detection of potentially related degradants. It is necessary to find suitable solvent and mobile phase samples that provide sufficient stability and compatibility with each component and potential impurities and degradants. This method should be carefully considered as it has the ability to distinguish between primary and secondary decomposers. The study of forced destruction of chemicals and new drugs is essential for the development and characterization of these immobilization methods. Practical guidance is provided at each stage of drug development to develop a forced disposal protocol and avoid common issues that might impede data interpretation. Suraj Nagwanshi | Smita Aher | Rishikesh Bachhav "Stability Indicating HPLC Method Development - A Review" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-5 , August 2021, URL: https://www.ijtsrd.com/papers/ijtsrd46310.pdf Paper URL: https://www.ijtsrd.com/pharmacy/other/46310/stability-indicating-hplc-method-development--a-review/suraj-nagwanshi
A Review HPLC Method Development and Validationijtsrd
Due to its very effective separations and often high detection sensitivity, HPLC is the most widely used separation method in contemporary pharmaceutical and biomedical analysis. The majority of medications in multiple component dosage forms can be examined using the HPLC method due to its many benefits, including speed, specificity, accuracy, precision, and ease of automation. The development and validation of HPLC procedures are crucial to novel discoveries, the creation of pharmaceutical medications, and numerous other investigations involving both humans and animals. To compare a defined characteristic of the drug substance or drug product to predetermined acceptance criteria for that characteristic, an analytical technique is designed. This review provides details on the numerous steps that go into developing and validating an HPLC technique. According to ICH Guidelines, validating an HPLC technique include testing for system appropriateness as well as accuracy, precision, specificity, linearity, range and limit of detection, limit of quantification, robustness, and other performance characteristics. Ajay Sanjay Salvi | Mohini S. Khamkar | Dr. Lahu D. Hingane "A Review: HPLC Method Development and Validation" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-4, August 2023, URL: https://www.ijtsrd.com/papers/ijtsrd58595.pdf Paper Url:https://www.ijtsrd.com/pharmacy/other/58595/a-review-hplc-method-development-and-validation/ajay-sanjay-salvi
CALIBRATION OF HPLC
Pressure Test.
Drift and Noise
Column oven and sample cooler
Pump by flow rate accuracy measurement.
Pump by gradient flow measurement.
UV-Vis / PDA detector by reference energy check.
The drug or drug combination may not be official in any pharmacopoeias.
A proper analytical procedure for the drug may not be available in the literature due to patent regulations.
Analytical methods may not be available for the drug in the form of a formulation due to the interference caused by the formulation excipients.
Analytical methods for the quantitation of the drug in biological fluids may not be available.
Analytical methods for a drug in combination with other drugs may not be available.
The existing analytical procedures may require expensive reagents and solvents. It may also involve cumbersome extraction and separation procedures and these may not be reliable.
Stability Indicating HPLC Method Development A Reviewijtsrd
High performance liquid chromatography HPLC is an essential analytical tool for evaluating drug stability. HPLC methods must be able to isolate, detect, and quantify drug related degradation products that may form during storage or production, and identify drug related impurities that may form during synthesis. .. This article describes strategies and challenges for designing HPLC methods to demonstrate drug stability. It will deepen our understanding of drugs and medicinal chemistry and demonstrate advances in stability that reflect an analytical approach. Several important chromatographic parameters were investigated to improve the detection of potentially related degradants. It is necessary to find suitable solvent and mobile phase samples that provide sufficient stability and compatibility with each component and potential impurities and degradants. This method should be carefully considered as it has the ability to distinguish between primary and secondary decomposers. The study of forced destruction of chemicals and new drugs is essential for the development and characterization of these immobilization methods. Practical guidance is provided at each stage of drug development to develop a forced disposal protocol and avoid common issues that might impede data interpretation. Suraj Nagwanshi | Smita Aher | Rishikesh Bachhav "Stability Indicating HPLC Method Development - A Review" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-5 , August 2021, URL: https://www.ijtsrd.com/papers/ijtsrd46310.pdf Paper URL: https://www.ijtsrd.com/pharmacy/other/46310/stability-indicating-hplc-method-development--a-review/suraj-nagwanshi
A Review HPLC Method Development and Validationijtsrd
Due to its very effective separations and often high detection sensitivity, HPLC is the most widely used separation method in contemporary pharmaceutical and biomedical analysis. The majority of medications in multiple component dosage forms can be examined using the HPLC method due to its many benefits, including speed, specificity, accuracy, precision, and ease of automation. The development and validation of HPLC procedures are crucial to novel discoveries, the creation of pharmaceutical medications, and numerous other investigations involving both humans and animals. To compare a defined characteristic of the drug substance or drug product to predetermined acceptance criteria for that characteristic, an analytical technique is designed. This review provides details on the numerous steps that go into developing and validating an HPLC technique. According to ICH Guidelines, validating an HPLC technique include testing for system appropriateness as well as accuracy, precision, specificity, linearity, range and limit of detection, limit of quantification, robustness, and other performance characteristics. Ajay Sanjay Salvi | Mohini S. Khamkar | Dr. Lahu D. Hingane "A Review: HPLC Method Development and Validation" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-4, August 2023, URL: https://www.ijtsrd.com/papers/ijtsrd58595.pdf Paper Url:https://www.ijtsrd.com/pharmacy/other/58595/a-review-hplc-method-development-and-validation/ajay-sanjay-salvi
A Review on Step-by-Step Analytical Method Validationiosrphr_editor
When analytical method is utilized to generate results about the characteristics of drug related samples it is essential that the results are trustworthy. They may be utilized as the basis for decisions relating to administering the drug to patients. Analytical method validation required during drug development and manufacturing and these analytical methods are fit for their intended purpose. To comply with the requirements of GMP pharmaceutical industries should have an overall validation policy which documents how validation will be performed. The purpose of this validation is to show that processes involved in the development and manufacture of drug, production and analytical testing can be performed in an effective and reproducible manner. This review article provides guidance on how to perform validation characteristics for the analytical method which are utilized in pharmaceutical analysis.
Review on Bioanalytical Method Development in Human Plasmaijtsrd
Bioanalytical methods are widely used to quantitate drugs and their metabolites in plasma matrices and this method are applied to study in the areas of human clinical and nonhuman study. Bioanalytical methods employed for the quantitative estimation of drugs and their metabolites plays an important role in estimation and interpretation of bioequivalence, pharmacokinetic, and toxicokinetic studies. The major bioanalytical role is method development, method validation, and sample analysis. Techniques such as high pressure liquid chromatography HPLC and liquid chromatography coupled with double mass spectrometry LCMS MS can be used for bioanalytical studies. Mayuri Gavhane | Dr. Ravindra Patil | Tejaswini Kande "Review on Bioanalytical Method Development in Human Plasma" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-7 , December 2022, URL: https://www.ijtsrd.com/papers/ijtsrd52578.pdf Paper URL: https://www.ijtsrd.com/chemistry/analytical-chemistry/52578/review-on-bioanalytical-method-development-in-human-plasma/mayuri-gavhane
A General Review on Bioanalytical Method Development & Validation for LC-MS/MSijtsrd
Rapid growth in the use of LC-MS/MS for the analysis of drugs in biological matrices has been compelled by the need for timely and high-quality data at every stages in drug discovery and development process: from throughput screening of drug candidates and rapid data generation for pre-clinical studies to almost 'real-time' analysis of clinical samples. A well developed bioanalytical development and its validation plays a pivotal role in achieving the goals. . The aim behind this review is to enlighten the need of validation which provide a practical approach for determining the different parameters like selectivity, specifity, limit of detection, lower limit of quantitation, linearity, range, accuracy, precision, recovery, stability, ruggedness, and robustness to help the perfect studies of pharmacokinetic, toxic kinetic, bioavailability and bioequivalence. Bio-analysis study is for the quantitative determination of drug and their metabolites in biological fluids. Accurate and robust methods for quantitative analysis of drug and their metabolites are important for the successful conduct of pre-clinical, bio-pharmaceutics and clinical pharmacology. Ashutosh Badola | Preeti Joshi | Preeti Kothiyal"A General Review on Bioanalytical Method Development & Validation for LC-MS/MS" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-2 | Issue-4 , June 2018, URL: http://www.ijtsrd.com/papers/ijtsrd14203.pdf http://www.ijtsrd.com/pharmacy/pharmaceutics/14203/a-general-review-on-bioanalytical-method-development-and-validation-for-lc-msms/ashutosh-badola
An Analysis on the UV-Visible Spectrophotometry MethodAI Publications
In the pharmaceutical industry, quality control is a necessary process. Pharmaceutical medicinal products must be advertised as safe, therapeutically active formulations with predictable qualities and performance. The main aim of the study is an analysis on the UV-Visible Spectrophotometry Method. UV spectroscopy was performed on Shimadzu 1700 uv spectrometer, 1cm cell quartz cuvette. Mode was set as UV mode and Detector wavelength was kept at 231 nm and 276 nm. A simple, rapid, accurate, sensitive and cost economical methodology for simultaneous estimation and precise ultraviolet radiation methodology has been developed and valid as per ICH guidelines for simultaneous Estimation of MET and AGP in Their Combined dose form.
Roadmap for Drug Product Development and Manufacturing of Biologics.pptxChintan Kalsariya
The development of therapeutic biologics involves a streamlined approach for their formulation and drug product development from early stages to process validation and commercialization.
This roadmap is based on experience with approved products and aims to improve safety, efficacy, and immunogenicity profiles in human patients, as well as maintain consistently high quality, efficiency, and reduced cost.
The approach should be applicable across all biotherapeutic products.
Recommendations on biomarker bioanalytical method validation by GCC (Global C...Wei Garofolo
The 5th GCC in Barcelona (Spain) and 6th GCC in San Antonio (TX, USA) closed forums provided a unique opportunity for CRO leaders to openly share opinions and perspectives, and to agree upon recommendations on biomarker bioanalytical method validation.
Blueprints to blue sky – analyzing the challenges and solutions for IHC compa...Candy Smellie
Manual assessment of biomarker expression is associated with significant inter- and intra reader variability. In some cases there are also limitations when it comes to sensitivity and specificity of manual biomarker assessment.
In one example to the left, the “pure” contribution of inter-reader variability associated with Ki67 assessment was quantified across 20 tumors and 126 participating labs. In that study, it was demonstrated how image analysis can be used to significantly reduce inter-reader variability.
In a another study, the National Danish Validation study of Her2, it was demonstrated how improved sensitivity/specificity of quantitative HER2 protein expression wrt gene amplification lead to significant cost savings in reflex testing.
By automating aspects of stain quality control, it will become scalable to he point where EQA organizations may be able and willing to offer more frequent – perhaps even on-demand – proficiency testing and calibration services.
It is possible that objective and quantitative standards will contribute to improve compliance with protocol recommendations.
In clinical multi-center trials it will be easier to standardize and monitor data from each center.
And it is our hope tha larger diagnostic pathology labs will be able to benefit from such a method by closely monitoring drift in staining quality for biomarkers.
WHO and ICH Guidelines for the Assessment of Herbal Drugijtsrd
The medicinal plant and herbal drugs products are widely used for thousands of years in all over the parts of the world. The word herbal drugs denoted plant parts or plants.That is converted into phytopharmaceuticals by means of straight forward processes including harvesting, drying, and storage. In recent few decades, growth and recognition of herbal medicine and plant products have taken a big share of healthcare.Theres the increasing awareness and general acceptability of the use of herbal drugs in todays practice Although, most of these applications are unorthodox, its however known fact that all over 80 of the world population are depends on herbal medicine and products for healthy living Where standardization and control with proper integration of recent scientific techniques and lore is incredibly important. This rise within the utilization of herbal product has also given to numerous forms of adulteration and abuse of the products leading to consumers and manufacturers disappointment. The challenge is innumerable and making the worldwide herbal market unsafe Evaluation of herbal drug showing an important and vital tool within the formulation of high quality herbal products. Herbal drug technology mainly used for converting botanical materials into medicines. Ms. Bhadane Suvarna | Dr. Takarkhede Smita | Ms. Kakade Pooja | Ms. Jaiswal Sangeeta | Ms. Kanaujiya Shreya | Ms. Khan Alqama "WHO & ICH Guidelines for the Assessment of Herbal Drug" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-3 , April 2022, URL: https://www.ijtsrd.com/papers/ijtsrd49571.pdf Paper URL: https://www.ijtsrd.com/pharmacy/other/49571/who-and-ich-guidelines-for-the-assessment-of-herbal-drug/ms-bhadane-suvarna
‘Six Sigma Technique’ A Journey Through its Implementationijtsrd
The manufacturing industries all over the world are facing tough challenges for growth, development and sustainability in today’s competitive environment. They have to achieve apex position by adapting with the global competitive environment by delivering goods and services at low cost, prime quality and better price to increase wealth and consumer satisfaction. Cost Management ensures profit, growth and sustainability of the business with implementation of Continuous Improvement Technique like Six Sigma. This leads to optimize Business performance. The method drives for customer satisfaction, low variation, reduction in waste and cycle time resulting into a competitive advantage over other industries which did not implement it. The main objective of this paper ‘Six Sigma Technique A Journey Through Its Implementation’ is to conceptualize the effectiveness of Six Sigma Technique through the journey of its implementation. Aditi Sunilkumar Ghosalkar "‘Six Sigma Technique’: A Journey Through its Implementation" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64546.pdf Paper Url: https://www.ijtsrd.com/other-scientific-research-area/other/64546/‘six-sigma-technique’-a-journey-through-its-implementation/aditi-sunilkumar-ghosalkar
Edge Computing in Space Enhancing Data Processing and Communication for Space...ijtsrd
Edge computing, a paradigm that involves processing data closer to its source, has gained significant attention for its potential to revolutionize data processing and communication in space missions. With the increasing complexity and data volume generated by modern space missions, traditional centralized computing approaches face challenges related to latency, bandwidth, and security. Edge computing in space, involving on board processing and analysis of data, offers promising solutions to these challenges. This paper explores the concept of edge computing in space, its benefits, applications, and future prospects in enhancing space missions. Manish Verma "Edge Computing in Space: Enhancing Data Processing and Communication for Space Missions" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64541.pdf Paper Url: https://www.ijtsrd.com/computer-science/artificial-intelligence/64541/edge-computing-in-space-enhancing-data-processing-and-communication-for-space-missions/manish-verma
Dynamics of Communal Politics in 21st Century India Challenges and Prospectsijtsrd
Communal politics in India has evolved through centuries, weaving a complex tapestry shaped by historical legacies, colonial influences, and contemporary socio political transformations. This research comprehensively examines the dynamics of communal politics in 21st century India, emphasizing its historical roots, socio political dynamics, economic implications, challenges, and prospects for mitigation. The historical perspective unravels the intricate interplay of religious identities and power dynamics from ancient civilizations to the impact of colonial rule, providing insights into the evolution of communalism. The socio political dynamics section delves into the contemporary manifestations, exploring the roles of identity politics, socio economic disparities, and globalization. The economic implications section highlights how communal politics intersects with economic issues, perpetuating disparities and influencing resource allocation. Challenges posed by communal politics are scrutinized, revealing multifaceted issues ranging from social fragmentation to threats against democratic values. The prospects for mitigation present a multifaceted approach, incorporating policy interventions, community engagement, and educational initiatives. The paper conducts a comparative analysis with international examples, identifying common patterns such as identity politics and economic disparities. It also examines unique challenges, emphasizing Indias diverse religious landscape, historical legacy, and secular framework. Lessons for effective strategies are drawn from international experiences, offering insights into inclusive policies, interfaith dialogue, media regulation, and global cooperation. By scrutinizing historical epochs, contemporary dynamics, economic implications, and international comparisons, this research provides a comprehensive understanding of communal politics in India. The proposed strategies for mitigation underscore the importance of a holistic approach to foster social harmony, inclusivity, and democratic values. Rose Hossain "Dynamics of Communal Politics in 21st Century India: Challenges and Prospects" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64528.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/history/64528/dynamics-of-communal-politics-in-21st-century-india-challenges-and-prospects/rose-hossain
Assess Perspective and Knowledge of Healthcare Providers Towards Elehealth in...ijtsrd
Background and Objective Telehealth has become a well known tool for the delivery of health care in Saudi Arabia, and the perspective and knowledge of healthcare providers are influential in the implementation, adoption and advancement of the method. This systematic review was conducted to examine the current literature base regarding telehealth and the related healthcare professional perspective and knowledge in the Kingdom of Saudi Arabia. Materials and Methods This systematic review was conducted by searching 7 databases including, MEDLINE, CINHAL, Web of Science, Scopus, PubMed, PsycINFO, and ProQuest Central. Studies on healthcare practitioners telehealth knowledge and perspectives published in English in Saudi Arabia from 2000 to 2023 were included. Boland directed this comprehensive review. The researchers examined each connected study using the AXIS tool, which evaluates cross sectional systematic reviews. Narrative synthesis was used to summarise and convey the data. Results Out of 1840 search results, 10 studies were included. Positive outlook and limited knowledge among providers were seen across trials. Healthcare professionals like telehealth for its ability to improve quality, access, and delivery, save time and money, and be successful. Age, gender, occupation, and work experience also affect health workers knowledge. In Saudi Arabia, healthcare professionals face inadequate expert assistance, patient privacy, internet connection concerns, lack of training courses, lack of telehealth understanding, and high costs while performing telemedicine. Conclusions Healthcare practitioners telehealth perceptions and knowledge were examined in this systematic study. Its collection of concerned experts different personal attitudes and expertise would help enhance telehealths implementation in Saudi Arabia, develop its healthcare delivery alternative, and eliminate frequent problems. Badriah Mousa I Mulayhi | Dr. Jomin George | Judy Jenkins "Assess Perspective and Knowledge of Healthcare Providers Towards Elehealth in Saudi Arabia: A Systematic Review" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64535.pdf Paper Url: https://www.ijtsrd.com/medicine/other/64535/assess-perspective-and-knowledge-of-healthcare-providers-towards-elehealth-in-saudi-arabia-a-systematic-review/badriah-mousa-i-mulayhi
The Impact of Digital Media on the Decentralization of Power and the Erosion ...ijtsrd
The impact of digital media on the distribution of power and the weakening of traditional gatekeepers has gained considerable attention in recent years. The adoption of digital technologies and the internet has resulted in declining influence and power for traditional gatekeepers such as publishing houses and news organizations. Simultaneously, digital media has facilitated the emergence of new voices and players in the media industry. Digital medias impact on power decentralization and gatekeeper erosion is visible in several ways. One significant aspect is the democratization of information, which enables anyone with an internet connection to publish and share content globally, leading to citizen journalism and bypassing traditional gatekeepers. Another aspect is the disruption of conventional media industry business models, as traditional organizations struggle to adjust to the decrease in advertising revenue and the rise of digital platforms. Alternative business models, such as subscription models and crowdfunding, have become more prevalent, leading to the emergence of new players. Overall, the impact of digital media on the distribution of power and the weakening of traditional gatekeepers has brought about significant changes in the media landscape and the way information is shared. Further research is required to fully comprehend the implications of these changes and their impact on society. Dr. Kusum Lata "The Impact of Digital Media on the Decentralization of Power and the Erosion of Traditional Gatekeepers" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64544.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/political-science/64544/the-impact-of-digital-media-on-the-decentralization-of-power-and-the-erosion-of-traditional-gatekeepers/dr-kusum-lata
Online Voices, Offline Impact Ambedkars Ideals and Socio Political Inclusion ...ijtsrd
This research investigates the nexus between online discussions on Dr. B.R. Ambedkars ideals and their impact on social inclusion among college students in Gurugram, Haryana. Surveying 240 students from 12 government colleges, findings indicate that 65 actively engage in online discussions, with 80 demonstrating moderate to high awareness of Ambedkars ideals. Statistically significant correlations reveal that higher online engagement correlates with increased awareness p 0.05 and perceived social inclusion. Variations across colleges and a notable effect of college type on perceived social inclusion highlight the influence of contextual factors. Furthermore, the intersectional analysis underscores nuanced differences based on gender, caste, and socio economic status. Dr. Kusum Lata "Online Voices, Offline Impact: Ambedkar's Ideals and Socio-Political Inclusion - A Study of Gurugram District" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64543.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/political-science/64543/online-voices-offline-impact-ambedkars-ideals-and-sociopolitical-inclusion--a-study-of-gurugram-district/dr-kusum-lata
Problems and Challenges of Agro Entreprenurship A Studyijtsrd
Noting calls for contextualizing Agro entrepreneurs problems and challenges of the agro entrepreneurs and for greater attention to the Role of entrepreneurs in agro entrepreneurship research, we conduct a systematic literature review of extent research in agriculture entrepreneurship to overcome the study objectives of complications of agro entrepreneurs through various factors, Development of agriculture products is a key factor for the overall economic growth of agro entrepreneurs Agro Entrepreneurs produces firsthand large scale employment, utilizes the labor and natural resources, This research outlines the problems of Weather and Soil Erosions, Market price fluctuation, stimulates labor cost problems, reduces concentration of Price volatility, Dependency on Intermediaries, induces Limited Bargaining Power, and Storage and Transportation Costs. This paper mainly devoted to highlight Problems and challenges faced for the sustainable of Agro Entrepreneurs in India. Vinay Prasad B "Problems and Challenges of Agro Entreprenurship - A Study" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64540.pdf Paper Url: https://www.ijtsrd.com/other-scientific-research-area/other/64540/problems-and-challenges-of-agro-entreprenurship--a-study/vinay-prasad-b
Comparative Analysis of Total Corporate Disclosure of Selected IT Companies o...ijtsrd
Disclosure is a process through which a business enterprise communicates with external parties. A corporate disclosure is communication of financial and non financial information of the activities of a business enterprise to the interested entities. Corporate disclosure is done through publishing annual reports. So corporate disclosure through annual reports plays a vital role in the life of all the companies and provides valuable information to investors. The basic objectives of corporate disclosure is to give a true and fair view of companies to the parties related either directly or indirectly like owner, government, creditors, shareholders etc. in the companies act, provisions have been made about mandatory and voluntary disclosure. The IT sector in India is rapidly growing, the trend to invest in the IT sector is rising and employment opportunities in IT sectors are also increasing. Therefore the IT sector is expected to have fair, full and adequate disclosure of all information. Unfair and incomplete disclosure may adversely affect the entire economy. A research study on disclosure practices of IT companies could play an important role in this regard. Hence, the present research study has been done to study and review comparative analysis of total corporate disclosure of selected IT companies of India and to put forward overall findings and suggestions with a view to increase disclosure score of these companies. The researcher hopes that the present research study will be helpful to all selected Companies for improving level of corporate disclosure through annual reports as well as the government, creditors, investors, all business organizations and upcoming researcher for comparative analyses of level of corporate disclosure with special reference to selected IT companies. Dr. Vaibhavi D. Thaker "Comparative Analysis of Total Corporate Disclosure of Selected IT Companies of India" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64539.pdf Paper Url: https://www.ijtsrd.com/other-scientific-research-area/other/64539/comparative-analysis-of-total-corporate-disclosure-of-selected-it-companies-of-india/dr-vaibhavi-d-thaker
The Impact of Educational Background and Professional Training on Human Right...ijtsrd
This study investigated the impact of educational background and professional training on human rights awareness among secondary school teachers in the Marathwada region of Maharashtra, India. The key findings reveal that higher levels of education, particularly a master’s degree, and fields of study related to education, humanities, or social sciences are associated with greater human rights awareness among teachers. Additionally, both pre service teacher training and in service professional development programs focused on human rights education significantly enhance teacher’s knowledge, skills, and competencies in promoting human rights principles in their classrooms. Baig Ameer Bee Mirza Abdul Aziz | Dr. Syed Azaz Ali Amjad Ali "The Impact of Educational Background and Professional Training on Human Rights Awareness among Secondary School Teachers" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64529.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/education/64529/the-impact-of-educational-background-and-professional-training-on-human-rights-awareness-among-secondary-school-teachers/baig-ameer-bee-mirza-abdul-aziz
A Study on the Effective Teaching Learning Process in English Curriculum at t...ijtsrd
“One Language sets you in a corridor for life. Two languages open every door along the way” Frank Smith English as a foreign language or as a second language has been ruling in India since the period of Lord Macaulay. But the question is how much we teach or learn English properly in our culture. Is there any scope to use English as a language rather than a subject How much we learn or teach English without any interference of mother language specially in the classroom teaching learning scenario in West Bengal By considering all these issues the researcher has attempted in this article to focus on the effective teaching learning process comparing to other traditional strategies in the field of English curriculum at the secondary level to investigate whether they fulfill the present teaching learning requirements or not by examining the validity of the present curriculum of English. The purpose of this study is to focus on the effectiveness of the systematic, scientific, sequential and logical transaction of the course between the teachers and the learners in the perspective of the 5Es programme that is engage, explore, explain, extend and evaluate. Sanchali Mondal | Santinath Sarkar "A Study on the Effective Teaching Learning Process in English Curriculum at the Secondary Level of West Bengal" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd62412.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/education/62412/a-study-on-the-effective-teaching-learning-process-in-english-curriculum-at-the-secondary-level-of-west-bengal/sanchali-mondal
The Role of Mentoring and Its Influence on the Effectiveness of the Teaching ...ijtsrd
This paper reports on a study which was conducted to investigate the role of mentoring and its influence on the effectiveness of the teaching of Physics in secondary schools in the South West Region of Cameroon. The study adopted the convergent parallel mixed methods design, focusing on respondents in secondary schools in the South West Region of Cameroon. Both quantitative and qualitative data were collected, analysed separately, and the results were compared to see if the findings confirm or disconfirm each other. The quantitative analysis found that majority of the respondents 72 of Physics teachers affirmed that they had more experienced colleagues as mentors to help build their confidence, improve their teaching, and help them improve their effectiveness and efficiency in guiding learners’ achievements. Only 28 of the respondents disagreed with these statements. With majority respondents 72 agreeing with the statements, it implies that in most secondary schools, experienced Physics teachers act as mentors to build teachers’ confidence in teaching and improving students’ learning. The interview qualitative data analysis summarized how secondary school Principals use meetings with mentors and mentees to promote mentorship in the school milieu. This has helped strengthen teachers’ classroom practices in secondary schools in the South West Region of Cameroon. With the results confirming each other, the study recommends that mentoring should focus on helping teachers employ social interactions and instructional practices feedback and clarity in teaching that have direct measurable impact on students’ learning achievements. Andrew Ngeim Sumba | Frederick Ebot Ashu | Peter Agborbechem Tambi "The Role of Mentoring and Its Influence on the Effectiveness of the Teaching of Physics in Secondary Schools in the South West Region of Cameroon" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64524.pdf Paper Url: https://www.ijtsrd.com/management/management-development/64524/the-role-of-mentoring-and-its-influence-on-the-effectiveness-of-the-teaching-of-physics-in-secondary-schools-in-the-south-west-region-of-cameroon/andrew-ngeim-sumba
Design Simulation and Hardware Construction of an Arduino Microcontroller Bas...ijtsrd
This study primarily focuses on the design of a high side buck converter using an Arduino microcontroller. The converter is specifically intended for use in DC DC applications, particularly in standalone solar PV systems where the PV output voltage exceeds the load or battery voltage. To evaluate the performance of the converter, simulation experiments are conducted using Proteus Software. These simulations provide insights into the input and output voltages, currents, powers, and efficiency under different state of charge SoC conditions of a 12V,70Ah rechargeable lead acid battery. Additionally, the hardware design of the converter is implemented, and practical data is collected through operation, monitoring, and recording. By comparing the simulation results with the practical results, the efficiency and performance of the designed converter are assessed. The findings indicate that while the buck converter is suitable for practical use in standalone PV systems, its efficiency is compromised due to a lower output current. Chan Myae Aung | Dr. Ei Mon "Design Simulation and Hardware Construction of an Arduino-Microcontroller Based DC-DC High-Side Buck Converter for Standalone PV System" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64518.pdf Paper Url: https://www.ijtsrd.com/engineering/mechanical-engineering/64518/design-simulation-and-hardware-construction-of-an-arduinomicrocontroller-based-dcdc-highside-buck-converter-for-standalone-pv-system/chan-myae-aung
Sustainable Energy by Paul A. Adekunte | Matthew N. O. Sadiku | Janet O. Sadikuijtsrd
Energy becomes sustainable if it meets the needs of the present without compromising the ability of future generations to meet their own needs. Some of the definitions of sustainable energy include the considerations of environmental aspects such as greenhouse gas emissions, social, and economic aspects such as energy poverty. Generally far more sustainable than fossil fuel are renewable energy sources such as wind, hydroelectric power, solar, and geothermal energy sources. Worthy of note is that some renewable energy projects, like the clearing of forests to produce biofuels, can cause severe environmental damage. The sustainability of nuclear power which is a low carbon source is highly debated because of concerns about radioactive waste, nuclear proliferation, and accidents. The switching from coal to natural gas has environmental benefits, including a lower climate impact, but could lead to delay in switching to more sustainable options. “Carbon capture and storage” can be built into power plants to remove the carbon dioxide CO2 emissions, but this technology is expensive and has rarely been implemented. Leading non renewable energy sources around the world is fossil fuels, coal, petroleum, and natural gas. Nuclear energy is usually considered another non renewable energy source, although nuclear energy itself is a renewable energy source, but the material used in nuclear power plants is not. The paper addresses the issue of sustainable energy, its attendant benefits to the future generation, and humanity in general. Paul A. Adekunte | Matthew N. O. Sadiku | Janet O. Sadiku "Sustainable Energy" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64534.pdf Paper Url: https://www.ijtsrd.com/engineering/electrical-engineering/64534/sustainable-energy/paul-a-adekunte
Concepts for Sudan Survey Act Implementations Executive Regulations and Stand...ijtsrd
This paper aims to outline the executive regulations, survey standards, and specifications required for the implementation of the Sudan Survey Act, and for regulating and organizing all surveying work activities in Sudan. The act has been discussed for more than 5 years. The Land Survey Act was initiated by the Sudan Survey Authority and all official legislations were headed by the Sudan Ministry of Justice till it was issued in 2022. The paper presents conceptual guidelines to be used for the Survey Act implementation and to regulate the survey work practice, standardizing the field surveys, processing, quality control, procedures, and the processes related to survey work carried out by the stakeholders and relevant authorities in Sudan. The conceptual guidelines are meant to improve the quality and harmonization of geospatial data and to aid decision making processes as well as geospatial information systems. The established comprehensive executive regulations will govern and regulate the implementation of the Sudan Survey Geomatics Act in all surveying and mapping practices undertaken by the Sudan Survey Authority SSA and state local survey departments for public or private sector organizations. The targeted standards and specifications include the reference frame, projection, coordinate systems, and the guidelines and specifications that must be followed in the field of survey work, processes, and mapping products. In the last few decades, there has been a growing awareness of the importance of geomatics activities and measurements on the Earths surface in space and time, together with observing and mapping the changes. In such cases, data must be captured promptly, standardized, and obtained with more accuracy and specified in much detail. The paper will also highlight the current situation in Sudan, the degree to which survey standards are used, the problems encountered, and the errors that arise from not using the standards and survey specifications. Kamal A. A. Sami "Concepts for Sudan Survey Act Implementations - Executive Regulations and Standards" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63484.pdf Paper Url: https://www.ijtsrd.com/engineering/civil-engineering/63484/concepts-for-sudan-survey-act-implementations--executive-regulations-and-standards/kamal-a-a-sami
Towards the Implementation of the Sudan Interpolated Geoid Model Khartoum Sta...ijtsrd
The discussions between ellipsoid and geoid have invoked many researchers during the recent decades, especially during the GNSS technology era, which had witnessed a great deal of development but still geoid undulation requires more investigations. To figure out a solution for Sudans local geoid, this research has tried to intake the possibility of determining the geoid model by following two approaches, gravimetric and geometrical geoid model determination, by making use of GNSS leveling benchmarks at Khartoum state. The Benchmarks are well distributed in the study area, in which, the horizontal coordinates and the height above the ellipsoid have been observed by GNSS while orthometric heights were carried out using precise leveling. The Global Geopotential Model GGM represented in EGM2008 has been exploited to figure out the geoid undulation at the benchmarks in the study area. This is followed by a fitting process, that has been done to suit the geoid undulation data which has been computed using GNSS leveling data and geoid undulation inspired by the EGM2008. Two geoid surfaces were created after the fitting process to ensure that they are identical and both of them could be counted for getting the same geoid undulation with an acceptable accuracy. In this respect, statistical operation played an important role in ensuring the consistency and integrity of the model by applying cross validation techniques splitting the data into training and testing datasets for building the geoid model and testing its eligibility. The geometrical solution for geoid undulation computation has been utilized by applying straightforward equations that facilitate the calculation of the geoid undulation directly through applying statistical techniques for the GNSS leveling data of the study area to get the common equation parameters values that could be utilized to calculate geoid undulation of any position in the study area within the claimed accuracy. Both systems were checked and proved eligible to be used within the study area with acceptable accuracy which may contribute to solving the geoid undulation problem in the Khartoum area, and be further generalized to determine the geoid model over the entire country, and this could be considered in the future, for regional and continental geoid model. Ahmed M. A. Mohammed. | Kamal A. A. Sami "Towards the Implementation of the Sudan Interpolated Geoid Model (Khartoum State Case Study)" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63483.pdf Paper Url: https://www.ijtsrd.com/engineering/civil-engineering/63483/towards-the-implementation-of-the-sudan-interpolated-geoid-model-khartoum-state-case-study/ahmed-m-a-mohammed
Activating Geospatial Information for Sudans Sustainable Investment Mapijtsrd
Sudan is witnessing an acceleration in the processes of development and transformation in the performance of government institutions to raise the productivity and investment efficiency of the government sector. The development plans and investment opportunities have focused on achieving national goals in various sectors. This paper aims to illuminate the path to the future and provide geospatial data and information to develop the investment climate and environment for all sized businesses, and to bridge the development gap between the Sudan states. The Sudan Survey Authority SSA is the main advisor to the Sudan Government in conducting surveying, mappings, designing, and developing systems related to geospatial data and information. In recent years, SSA made a strategic partnership with the Ministry of Investment to activate Geospatial Information for Sudans Sustainable Investment and in particular, for the preparation and implementation of the Sudan investment map, based on the directives and objectives of the Ministry of Investment MI in Sudan. This paper comes within the framework of activating the efforts of the Ministry of Investment to develop technical investment services by applying techniques adopted by the Ministry and its strategic partners for advancing investment processes in the country. Kamal A. A. Sami "Activating Geospatial Information for Sudan's Sustainable Investment Map" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63482.pdf Paper Url: https://www.ijtsrd.com/engineering/information-technology/63482/activating-geospatial-information-for-sudans-sustainable-investment-map/kamal-a-a-sami
Educational Unity Embracing Diversity for a Stronger Societyijtsrd
In a rapidly changing global landscape, the importance of education as a unifying force cannot be overstated. This paper explores the crucial role of educational unity in fostering a stronger and more inclusive society through the embrace of diversity. By examining the benefits of diverse learning environments, the paper aims to highlight the positive impact on societal strength. The discussion encompasses various dimensions, from curriculum design to classroom dynamics, and emphasizes the need for educational institutions to become catalysts for unity in diversity. It highlights the need for a paradigm shift in educational policies, curricula, and pedagogical approaches to ensure that they are reflective of the diverse fabric of society. This paper also addresses the challenges associated with implementing inclusive educational practices and offers practical strategies for overcoming barriers. It advocates for collaborative efforts between educational institutions, policymakers, and communities to create a supportive ecosystem that promotes diversity and unity. Mr. Amit Adhikari | Madhumita Teli | Gopal Adhikari "Educational Unity: Embracing Diversity for a Stronger Society" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64525.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/education/64525/educational-unity-embracing-diversity-for-a-stronger-society/mr-amit-adhikari
Integration of Indian Indigenous Knowledge System in Management Prospects and...ijtsrd
The diversity of indigenous knowledge systems in India is vast and can vary significantly between different communities and regions. Preserving and respecting these knowledge systems is crucial for maintaining cultural heritage, promoting sustainable practices, and fostering cross cultural understanding. In this paper, an overview of the prospects and challenges associated with incorporating Indian indigenous knowledge into management is explored. It is found that IIKS helps in management in many areas like sustainable development, tourism, food security, natural resource management, cultural preservation and innovation, etc. However, IIKS integration with management faces some challenges in the form of a lack of documentation, cultural sensitivity, language barriers legal framework, etc. Savita Lathwal "Integration of Indian Indigenous Knowledge System in Management: Prospects and Challenges" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63500.pdf Paper Url: https://www.ijtsrd.com/management/accounting-and-finance/63500/integration-of-indian-indigenous-knowledge-system-in-management-prospects-and-challenges/savita-lathwal
DeepMask Transforming Face Mask Identification for Better Pandemic Control in...ijtsrd
The COVID 19 pandemic has highlighted the crucial need of preventive measures, with widespread use of face masks being a key method for slowing the viruss spread. This research investigates face mask identification using deep learning as a technological solution to be reducing the risk of coronavirus transmission. The proposed method uses state of the art convolutional neural networks CNNs and transfer learning to automatically recognize persons who are not wearing masks in a variety of circumstances. We discuss how this strategy improves public health and safety by providing an efficient manner of enforcing mask wearing standards. The report also discusses the obstacles, ethical concerns, and prospective applications of face mask detection systems in the ongoing fight against the pandemic. Dilip Kumar Sharma | Aaditya Yadav "DeepMask: Transforming Face Mask Identification for Better Pandemic Control in the COVID-19 Era" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64522.pdf Paper Url: https://www.ijtsrd.com/engineering/electronics-and-communication-engineering/64522/deepmask-transforming-face-mask-identification-for-better-pandemic-control-in-the-covid19-era/dilip-kumar-sharma
Streamlining Data Collection eCRF Design and Machine Learningijtsrd
Efficient and accurate data collection is paramount in clinical trials, and the design of Electronic Case Report Forms eCRFs plays a pivotal role in streamlining this process. This paper explores the integration of machine learning techniques in the design and implementation of eCRFs to enhance data collection efficiency. We delve into the synergies between eCRF design principles and machine learning algorithms, aiming to optimize data quality, reduce errors, and expedite the overall data collection process. The application of machine learning in eCRF design brings forth innovative approaches to data validation, anomaly detection, and real time adaptability. This paper discusses the benefits, challenges, and future prospects of leveraging machine learning in eCRF design for streamlined and advanced data collection in clinical trials. Dhanalakshmi D | Vijaya Lakshmi Kannareddy "Streamlining Data Collection: eCRF Design and Machine Learning" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63515.pdf Paper Url: https://www.ijtsrd.com/biological-science/biotechnology/63515/streamlining-data-collection-ecrf-design-and-machine-learning/dhanalakshmi-d
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
Francesca Gottschalk - How can education support child empowerment.pptxEduSkills OECD
Francesca Gottschalk from the OECD’s Centre for Educational Research and Innovation presents at the Ask an Expert Webinar: How can education support child empowerment?
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
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suitable for analysis (i.e. suitable wavelength in case
of UV detection).[7] The majority of the analytical
development effort goes into validating a stability
indicating HPLC method. The goal of the HPLC
method is to separate quantify the main active drug,
any reaction impurities, all available synthetic inter-
mediate and any degradants. Steps involve in method
development are:
1. Qualified and calibrated instrument
2. Documented methods
3. Reliable reference standards
4. Qualified analysts
5. Sample selection and integrity
6. The analysis should take a minimal time and
should be economical.
7. The accuracy of the analyst must accept the
guidelines of pharmacopoeia.
8. The chosen method should be precise and
selective.
9. Set up HPLC conditions.
10. Preparation of sample solution for method
development.
11. Method optimisation.
12. Development and validation of method.[8]
PURPOSE OF ANALYTICAL METHOD
DEVELOPMENT:
Drug analysis reveals the identification,
characterisation and determination of the medication
in mixtures like indefinite quantity forms and
biological fluids. Throughout producing method and
drug development the most purpose of analytical
ways is to produce info regarding efficiency (which is
directly associated with the need of a notable dose),
impurity (related to safety profile of the drug),
bioavailability (includes key drug characteristics a
like crystal type, drug uniformity and drug release),
stability (which indicated the degradation products),
and impact of producing parameters to make sure that
the assembly of drug merchandise in consistent.[9]
The idea of internal control is meant to look at and
establish a real and right product by series of
measures designed to avoid and find eliminate errors
at varied stages in production. To require a choice to
unharness or discard a product relies on one or lot of
forms of management action. Proving easy and
analytical method for varied complicated formulation
may be a subject material of utmost importance. Fast
increase in pharmaceutical industries and constant
production of drug in varied components of the globe
has brought a fast rise in demand for a brand new
analytical techniques within the pharmaceutical
industries as a consequence; analytical methodology
development has become the essential activity of
study during internal control laboratory.[9]
METHOD DEVELOPMENT ON HPLC:
A steps involved in method development of HPLC is as follows:
1. Understanding the Physiochemical properties of drug molecule.
2. Selection of chromatographic condition
3. Developing the approach of analysis
4. Sample preparations
5. Method optimization
6. Method validation
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Understanding the Physiochemical properties of drug molecule
Physiochemical properties of a drug molecule play an important role in method development. For method
development one has to study the physical properties like solubility, polarity, pKa and pH of the drug molecule.
Polarity is a physical property of a compound. It helps an analyst, to decide the solvent and composition n of the
mobile phase.
The solubility of molecules can be explained on the basis of the polarity of molecules. Polar, e.g. water, and
nonpolar, e.g. benzene, solvents do not mix. In general, like dissolves like i.e., materials with similar polarity are
soluble in each other. The selection of mobile phase or diluents is based on the solubility of analyte. The analyte
must be soluble in diluents and must not react with any of its component. pH and pKa plays an important role in
HPLC method development. The pH value is defined as the negative of the logarithm to base 10 of the
concentration of the hydrogen ion.
pH = - log10[H3O+].
Selecting a proper pH for ionizable analytes often leads to symmetrical and sharp peaks in HPLC. Sharp,
symmetrical peaks are necessary in quantitative analysis in order to achieve low detection limits, low relative
standard deviations between injections, and reproducible retention times.[10-11]
1. Selection of chromatographic condition :
Selection of column: Selection of the stationary phase/column is the first and the most important step in method
development. The development of rugged and reproducible method is impossible without the availability of a
stable, high performance column. To avoid problems from irreproducible sample retention during method
development, it is important that columns be stable and reproducible.
C8 or C18 column made from specially purified, less acidic silica and designed specially for the separation of
basic compounds is generally suitable for all samples and is strong recommended. [12] Column dimension, silica
substrate properties and bonded stationary phase characteristics are the main ones. The use of silica based
packing is favoured in the most of present HPLC columns due to several physical characteristics.[13]
Buffer Selection: Choice of buffer is governed by the pH that is desired. The typical pH range for reversed
phase on silica based packing is pH 2 to 8. It Is important that the buffer has a pKa close to the desired pH since
buffer controls pH best at their pKa. A rule is to choose a buffer with a pKa value <2 units of the desired mobile
phase pH.
General consideration for buffer selection:
1. Phosphate is more soluble in methanol/water than in acetonitrile/water or THF/water.
2. Some salt buffers are hygroscopic and this may lead to changes in the chromatography like increased tailing
of basic compounds and possibly selectivity differences.
3. Ammonium salts are generally more soluble in organic/water mobile phases.
4. Trifluoroacetic acid can degrade with time. It is volatile and absorbs at low UV wavelengths.
5. Microbial growth can quickly occur in buffered mobile phases that contain little or no organic modifier at all.
The growth accumulates on column inlets and can damage chromatographic performance.
6. At pH greater than 7, phosphate buffer accelerate the dissolution of silica and severely shortness the lifetime
of silica – based HPLC columns. If possible, organic buffers should be used at pH greater than 7.
7. Ammonium bicarbonate buffers usually are prone to pH changes and are usually stable for only 24-48 hours.
The pH of this mobile phase tends to become more basic due to to the release of carbon dioxide.
8. After buffers are prepare, they should be filtered through a 0.2micrometer filter.
9. Mobile phase should be degassed.[14]
Buffer concentration: Generally, a buffer concentration of 10-50 mm is adequate for small molecule.
Generally, no more than 50% organic should be used with a buffer. This will depend on the specific buffer as
well as its concentration. Phosphoric acid and its sodium or potassium salt are the most common buffer system
for reversed-phase HPLC. Sulfonate buffers can replace phosphate buffers when analysing organophosphate
compounds.[15]
Isocratic and gradient separations: Isocratic mode of separation includes constant eluent composition ; means
equilibrium conditions in the column and the actual velocity of compounds moving through the column are
constant. The peak capacity is low and the longer the component is retained on the column the wider is the
resultant peak. Gradient mode of separation includes significantly increase the separation bower of the system
mainly due to increase of the apparent efficiency (decrease of the peak width ). Peak width varies depending on
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the rate of the eluent composition variation. In deciding whether a gradient on isocratic would be required and
initial gradient run is performed and ratio between the total gradient time and the difference in the gradient time
between the first and last components are calculated. The calculated ratio is <0.25 isocratic is adequate. When
the ratio is >0.25 gradient would be adequate.[16]
Internal Diameter: The internal diameter (ID) of an HPLC column is important parameter that influence the
detection sensitivity and separation selectivity in gradient elution. It also determines the quantity of analyte that
can be loaded into a column.[17]
Particle size: Most traditional HPLC is performed with the stationary phase attached to the outside of small
spherical silica particles. These silica particles come in many sizes with 5 micro meter beads being the most
commonly used. The smaller particles usually provide more surface area and better separation but pressure
required for the optimum linear velocity increases by the inverse of the particles dimeter squared. Larger
particles are used in preparative HPLC where column diameters are in range of 5 cm to >30 cm and for non-
HPLC such as solid-phase extractions.[18-19]
Pore size: Pore size of column defines an ability of the analyte molecules to penetrate inside the particle and
interact with its inner surface.[20]
Selection of Mobile phase: The mobile phase effects resolution, selectivity and efficiency. Mobile phase
composition (or solvent strength) plays and important role in RP-HPLC separation. Acetonitrile (ACN),
methanol (MeOH) and tetrahydrofuran (THF) are commonly used solvents in RP-HPLC having low UV cut-off
of 190, 205 and 212nm respectively. These solvents are miscible with water. Mixture of acetonitrile and water is
the best initial choice for the mobile phase during method development.[21]
Mode Solvent type used Type of compound used
Reversed Phase
Water/Buffer, CAN,
Methanol
Neutral or non-ionized compounds which
can be dissolved in water/organic mixtures.
Ion-pair
Water/Buffer, ACN,
Methanol
Ionic or Ionizable compounds
Normal phase Organic solvents
Mixtures of isomers and compounds not
soluble in Organic/Water mixtures.
Ion exchange Water/Buffers
Inorganic ions proteins, nucleic acids,
organic acids.
Size exclusion
Water, Tetrahydrofuran
Chloroform
High molecular weight compounds
Selection of detectors: Detector is a very important part of HPLC. Selection of detector depends on the
chemical nature of analyses, potential interference, limit of detection required , availability and/or cost of
detector. UV-visible detector is versatile, dual wavelength absorbance detector for HPLC. This detector offers
the high sensitivity required for routine UV-based applications to low-level impurity identification and
quantitative analysis. Photodiode Array (PDA). Detector offers advanced optical detection for Waters analytical
HPLC, preparative HPLC, or LC/MS system solutions. Its integrated software and optics innovations delivers
high chromatographic and spectral sensitivity. Refractive index chromatographic and spectral sensitivity,
stability and reproducibility, which makes this detector the ideal solution for analysis of components with
limited or no UV absorption. Multi-wavelength Fluorescence Detector offers high sensitivity and selectivity
fluorescence detection for quantitating low concentrations of target compounds. [22-23]
Detector Type of component can be detected
UV visible and photodiode array
Compounds with chromophores such as aromatic rings
or multiple alternating double bonds
Fluorescence detector
Fluorescent compounds, usually with fused rings or
highly conjugated planar system.
Conductivity detector
Charged compounds, such as inorganic ions and
organic acids.
Electrochemical detector
For easily oxidized compounds like quinines or
amines.
Refractive index detector and
Evaporative light scattering detector
Compounds that do not show characteristics usable by
the other detectors, eg. polymers, saccharides.
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2. Developing the approach for analysis: While developing the analytical method on RP-HPLC the first step
is followed is the selections of various chromatographic parameters like selection of mobile phase, selection
of column, selection of flow rate of mobile phase, selection of pH of mobile phase. All of these parameters
are selected on the basis of trials and followed by considering the system suitability parameters. Typical
parameters of system suitability are e.g. retention time should be more than 5min, the theoretical plates
should be more than 2000, the tailing factor should be less than 2, resolution between 2 peaks should be
more than 5, % R.S.D of the area of analyte peaks in standard chromatograms should not be more than 2.0%
like other. Detection wavelength is usually isobestic point in the case of simultaneous estimation of 2
components. After this the linearity of the drug is studied in order to know the range of concentrations up to
which the drug follows the linear pattern. Analysis of the laboratory mixture is also carried out in order to
know practicability of developed method for simultaneous estimation. After that analysis of marketed
formulation is carried out by diluting the marketed formulation up to concentration range of linearity.[24-29,
45]
3. Sample preparation: Sample preparation is an essential part of HPLC analysis, intended to provide a
reproducible and homogeneous solution that is suitable for injection onto the column. The aim of sample
preparation is a sample aliquot that, is relatively free of interferences, will not damage the column, and is
compatible with the intended HPLC method that is, the sample solvent will dissolve in the mobile phase
without affecting sample retention or resolution. Sample preparation begins at the point of collection,
extends to sample injection onto the HPLC column.[30]
4. Method optimization: Identify the “weakness” of the method and optimize the method through
experimental design. Understand the method performance with different conditions, different instrument set
ups and different samples.[31]
5. Method validation: Validation is the confirmation by examination and the provision of objective evidence
that the particular requirements for a specific intended use are fulfilled. A process of evaluating method
performance and demonstrating that it meets a particular requirements. In essence, it knows what your
method is capable of delivering, particularly at low concentrations.[32]
Need of pharmaceutical validation: Validation is an integral part of quality assurance; it involves the
systematic study of systems, facilities and processes aimed at determining whether they perform their intended
functions adequately and consistently as specified. A valid method is one that has been incontestable to supply a
high degree of assurance that uniform batches are made that meet the desired specifications and has therefore
been formally approved. Validation in itself does not improve processes but confirms that the processes have
been properly developed and are under control. [33]
Types of analytical procedures to be validated :
The discussion of the validation of analytical procedures is directed to the four most common types of analytical
procedures:
Identification tests
Quantitative tests for impurities content
Limit tests for the control of impurities
Quantitative tests of the active moiety in samples of drug substance or drug substance or drug product or
other selected components in the drug product.[34]
Components of method validation :The following are typical analytical performance characteristics which may
be tested during methods validation :
1. Accuracy
2. Precision
3. Linearity
4. Limit of Detection
5. Limit of Quantification
6. Specificity
7. Range
8. Robustness
Accuracy
Accuracy is defined as the nearness of a measured value to the true accepted value. Practically accuracy
indicates the deviation between the mean value found and the true value. It is determine by applying the method
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to samples to which known amounts of analyte have been added. These should be analysed against standard and
blank solutions to ensure that no interferences exists. The accuracy is then calculated from the test results as a
percentage of the analyte recovered by the assay. It may often be expressed as the recovery by the assay of
known, added amounts of analyte.[35]
Precision
It expresses closeness of agreement (degree of scatter) between a series of measurements obtained from multiple
sampling of the same Homogeneous sample under the prescribed conditions. Precision is a Measure of the
reproducibility of the whole analytical method.[36] It consists of two components repeatability and intermediate
precision. Repeatability is the variation experienced by a single analyst on a single instrument. It does not
distinguish between variation from the instrument or system alone and from the sample preparation process.
During validation, repeatability is performed by analysing multiple replicates of an assay composite sample by
using the analytical method. The recovery value is calculated. Intermediate precision is the variation within a
laboratory such as different days, with different instruments, and by different analysts.[37-38] The precision then
expressed as the relative standard deviation.
%RSD = Standard deviation X 100 / mean
Accuracy and precision are not the same, as the diagram below Indicates. A method can have good precision
and yet not be accurate.
Linearity
The Linearity of an analytical method may be defined
as “Its ability to elicit tests that are directly or by well
defined mathematical transformations proportional to
the concentration of analyte in samples within a given
range.[39]
Limit of Detection (LOD)
Limit of detection (LOD) of an individual procedure
is the lowest amount of analyte in a sample that can
be detected but not necessarily quantitated as an exact
value. In analytical procedures that exhibit baseline
noise, the LOD can be based on a signal-to-noise
(S/N) ratio (3:1), which is usually expressed as the
concentration of analyte in the sample. The signal-to-
noise ratio is determined by: s = H/h Where H =
height of the
peak corresponding to the component. h = absolute
value of the largest noise fluctuation from the
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baseline of the chromatogram of a blank
solution.[40-42,47]
Limit of Quantification (LOQ)
The limit of Quantitation (LOQ) or Quantitation limit
of an individual analytical procedure is the lowest
amount of analyte in a sample that can be
quantitatively determined with suitable precision and
accuracy.
For analytical procedures such as HPLC that exhibit
baseline noise, the LOQ is generally estimated from
exhibit baseline noise, the LOQ is generally estimated
from a determination of S/N ratio (10:1) and is
usually confirmed by injecting standards which give
this S/N ratio and have an acceptable percent relative
standard deviation as well.[41-42]
Specificity
Selectivity of an analytical method as its ability to
measure accurately an analyte in the presence of
interference, such as synthetic precursors, excipients,
enantiomers, and known (or likely) degradation
products that may be expected to be present in the
sample matrix.[43]
Range
The range of the method is the interval between the
upper and lower levels of an analyte that have been
determined with acceptable precision, accuracy and
linearity. It is determined on either a linear or
nonlinear response curve (ie where more than one
range is involved) and is normally expressed in the
same units as the test results. [44]
Robustness
Robustness is defined as the measure of the ability of
an analytical method to remain unaffected by small
but deliberate variations in method parameters (e.g.
pH, mobile phase composition, temperature and
instrumental settings) and provides an indication of
its reliability during normal usage. Determination of
robustness is a systematic process of varying a
parameter and measuring the effect on the method by
monitoring system suitability and the analysis of
samples.[40-41)
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