Formulation and Evaluation of Amlodipine Fast Dissolving Tabletsijtsrd
Fast dissolving tablet is a new era for successful development of controlled release formulation along with various features to provide successful drug delivery. In the present study, an attempt was made to design and evaluate fast dissolving tablets of Amlodipine besylate, which is used commonly for the treatment of angina pectoris. The tablets were prepared by direct compression method followed by sublimation method using super disintegrants sodium starch glycolate, crosspovidone and croscarmellose sodium. The prepared powder blends were evaluated for preformulation parameters. The tablets were evaluated for thickness, hardness, weight variation, drug content uniformity, friability and in vitro drug release studies. In vitro drug release studies were performed by using USP type II apparatus paddle method at 50 rpm in 900 ml of 0.1N HCl as dissolution medium for 30 minutes at 37±0.5°C. The formulation F9 containing Croscarmellose sodium 7 showed better disintegration and dissolution up to 30 minutes. Hence, formulation F9 was considered as optimized formulation which showed the best drug release profile up to 30 minutes. The results of mathematical model fitting of data obtained indicated that, the best fit model in all the cases the release was found to be by diffusion and fickian release. The results of FTIR analysis showed that there was no physical and chemical interaction between drug and other excipients. The study indicates that the fast dissolving tablets of Amlodipine besylate can effectively reduce the adverse effects and frequency of administration of the drug. Aparna. P | Dr. Subash Chandran M. P | Remya S B "Formulation and Evaluation of Amlodipine Fast Dissolving Tablets" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-1 , December 2019, URL: https://www.ijtsrd.com/papers/ijtsrd29563.pdfPaper URL: https://www.ijtsrd.com/pharmacy/pharmaceutics/29563/formulation-and-evaluation-of-amlodipine-fast-dissolving-tablets/aparna-p
regulatory affairs m.pharm pharmaceutics - Non clinical drug development: Global submission of IND, NDA, ANDA.
Investigation of medicinal products dossier, dossier (IMPD) and investigator brochure (IB)
Formulary is an official or authorised publication of an approved list of medicines for use in a hospital, a group of hospitals a society a state or a region a country or a number of countries.
Hospital Formulary is a continually revised compilation of pharmaceuticals dosage agents and their forms that reflects the current clinical view of the medical staff.
Formulation and Evaluation of Amlodipine Fast Dissolving Tabletsijtsrd
Fast dissolving tablet is a new era for successful development of controlled release formulation along with various features to provide successful drug delivery. In the present study, an attempt was made to design and evaluate fast dissolving tablets of Amlodipine besylate, which is used commonly for the treatment of angina pectoris. The tablets were prepared by direct compression method followed by sublimation method using super disintegrants sodium starch glycolate, crosspovidone and croscarmellose sodium. The prepared powder blends were evaluated for preformulation parameters. The tablets were evaluated for thickness, hardness, weight variation, drug content uniformity, friability and in vitro drug release studies. In vitro drug release studies were performed by using USP type II apparatus paddle method at 50 rpm in 900 ml of 0.1N HCl as dissolution medium for 30 minutes at 37±0.5°C. The formulation F9 containing Croscarmellose sodium 7 showed better disintegration and dissolution up to 30 minutes. Hence, formulation F9 was considered as optimized formulation which showed the best drug release profile up to 30 minutes. The results of mathematical model fitting of data obtained indicated that, the best fit model in all the cases the release was found to be by diffusion and fickian release. The results of FTIR analysis showed that there was no physical and chemical interaction between drug and other excipients. The study indicates that the fast dissolving tablets of Amlodipine besylate can effectively reduce the adverse effects and frequency of administration of the drug. Aparna. P | Dr. Subash Chandran M. P | Remya S B "Formulation and Evaluation of Amlodipine Fast Dissolving Tablets" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-1 , December 2019, URL: https://www.ijtsrd.com/papers/ijtsrd29563.pdfPaper URL: https://www.ijtsrd.com/pharmacy/pharmaceutics/29563/formulation-and-evaluation-of-amlodipine-fast-dissolving-tablets/aparna-p
regulatory affairs m.pharm pharmaceutics - Non clinical drug development: Global submission of IND, NDA, ANDA.
Investigation of medicinal products dossier, dossier (IMPD) and investigator brochure (IB)
Formulary is an official or authorised publication of an approved list of medicines for use in a hospital, a group of hospitals a society a state or a region a country or a number of countries.
Hospital Formulary is a continually revised compilation of pharmaceuticals dosage agents and their forms that reflects the current clinical view of the medical staff.
Introduction to clinical pharmacy, Concept and Objectives of clinical pharmacy, Function and responsibilities of clinical pharmacist, Clinical Pharmacy services.
Hospital Formulary - presentation gives the detail idea about Hospital formulary, its advantage, disadvantage, how to prepare Hospital formulary and much more. this will be useful for Pharm.D-IV YEAR students, which was in their Hospital pharmacy subject. regards APOLLOJAMES
Drug Information Services, Drug information Sources, Illegal DIC, Drug Information Bulletin, Classification of scientific literature, services offered bu drug information services
Video Lecture is available at https://www.youtube.com/watch?v=DXu_CLgB4q0
Introduction, terminology/definitions and rationale, advantages, disadvantages, selection of drug candidates. Approaches to design-controlled release formulations based on diffusion, dissolution and ion exchange principles. Physicochemical and
biological properties of drugs relevant to controlled release formulations.
Community pharmacy-Definition ,scope and Roles and responsibilities of commun...MerrinJoseph1
Second Pharm D , Community Pharmacy -first chapter,definition of community pharmacy,its scope and the roles and responsibilities of community pharmacist in health care of common people,Dr.Merrin Joseph,Department of pharmacy practice
Introduction to clinical pharmacy, Concept and Objectives of clinical pharmacy, Function and responsibilities of clinical pharmacist, Clinical Pharmacy services.
Hospital Formulary - presentation gives the detail idea about Hospital formulary, its advantage, disadvantage, how to prepare Hospital formulary and much more. this will be useful for Pharm.D-IV YEAR students, which was in their Hospital pharmacy subject. regards APOLLOJAMES
Drug Information Services, Drug information Sources, Illegal DIC, Drug Information Bulletin, Classification of scientific literature, services offered bu drug information services
Video Lecture is available at https://www.youtube.com/watch?v=DXu_CLgB4q0
Introduction, terminology/definitions and rationale, advantages, disadvantages, selection of drug candidates. Approaches to design-controlled release formulations based on diffusion, dissolution and ion exchange principles. Physicochemical and
biological properties of drugs relevant to controlled release formulations.
Community pharmacy-Definition ,scope and Roles and responsibilities of commun...MerrinJoseph1
Second Pharm D , Community Pharmacy -first chapter,definition of community pharmacy,its scope and the roles and responsibilities of community pharmacist in health care of common people,Dr.Merrin Joseph,Department of pharmacy practice
ABSTRACT
Overactive bladder (OAB) is a prevalent condition which has an adverse effect on quality of life. The presence
of urgency incontinence confers significant morbidity above and beyond that of OAB sufferers who are
continent. The primary treatment for OAB and urgency incontinence is a combination of behavioral measures
and antimuscarinic drug therapy. The ideal antimuscarinic agent should effectively relieve the symptoms of
OAB, with the minimum of side effects; it should be available as a once-daily sustained release formulation
and in dosage strength that allows easy dose titration for the majority of sufferers. Solifenacin succinate was
launched in 2005 and has been shown in both short and long term clinical trials to fulfill these requirements.
Solifenacin is a competitive M3 receptor antagonist with a long half-life (45-68 hours). It is available in two
dosage strengths namely a 5 or 10 mg once-daily tablet. The efficacy and tolerability of solifenacin for the
treatment of all symptoms of OAB has been evaluated in a number of large, placebo controlled, randomized
trials. Long-term safety, efficacy, tolerability and persistence with treatment have been established in an open
label 40 week continuation study.
KEYWORDS
Solifenacin, Urinary incontinence, Overactive bladder and Wet granulation method.
QUALITY CONTROL OF TABLETS IPQC stands for in process quality control. These are checks that are carried out before the manufacturing process is completed.
2.6.12. microbiological examination of non sterile products (total viable aer...Guide_Consulting
Salah Satu Referensi Yang Digunakan Dalam One Day Seminar "Preservative Effectiveness Validation"
04 Desember 2014. Bogor
Detail : info@traininglaboratorium.com
Formulation and evaluation of gastroretentative floating sustained releasedme...Sagar Savale
The Metformin HCL Gastroretentative Floating Sustained released Tablet is formulated by the Wet
Granulation technique. This Tablet is containing both Effervescent as well as Non Effervescent system. The
HPMC K 100 Swellable polymer is responsible for the Floating. (Non-Effervescent system) and The Sodium
Bicarbonate is responsible for the effervescent system. A combination of HPMC K 100 and Xanthum Gum
shows better sustained release activity. The Prepared Gastroretentative Floating Sustained released Tablet is
Evaluated In terms of bulk density, tapped density, angle of repose, Carr’s Index and, weight variation test,
friability test and in vitro study, Total Floating Time. The result associated in Optimized batch is good to
Satisfactory and having a good free flowing property. The weight variation and friability these values are
within the pharmacopeia limit. The in vitro Dissolution studies show Maximum percentage of release of drug
(99.25) within end of 8 Hours.
ABSTRACT
Hyperglycemia is the technical term for high blood glucose (sugar). It
happens when the body has too little or not enough insulin or when the
body can‘t use insulin properly. The main objective of the present
research work was to develop a bilayer tablet of immediate release
Pioglitazone and controlled release Metformin Hydrochloride, which is
used as an Anti-hyperglycemic agent. Metformin Hydrochloride has
biological half-life nearly about 6 hours, so, an attempt was made in
the direction of preparation and optimization of a combination of
sustained release and immediate release in a single tablet. In controlled
release layer natural gums like xanthum gum, gum trgacanth and guar
gum were used as retarding materials and in immediate release laye
croscarmellose sodium was used as a superdisintegrent to give the faster release of
pioglitazone. The tablets were prepared by wet granulation method and by direct
compression. Granules were evaluated for precompression parameters and the tablets were
evaluated for post compression parameters.
Key Words: Bilayer tablets, Metformin Hydrochloride, pioglitazone, xanthum gum, guar
gum, gum tragacanth and crosscarmellose sodium.
Spectrophotometric Estimation of Rosuvastatin Calcium in Bulk and Pharmaceuti...SriramNagarajan15
Rosuvastatin calcium of the class statins is used for primary hyperlipidemias. It is a selective and competitive inhibitor of HMG-CoA reductase. In the present work, simple, sensitive and economic spectrophotometric method has been developed for quantitative determination of Rosuvastatin calcium. In the present spectrophotometric method Rosuvastatin calcium was dissolved in double distilled water. It exhibited an absorption maximum at 241 nm and obeyed Beer’s law in the concentration range of 5-25g/ml. The results of analysis have been validated and found to be sensitive, precise and accurate for quantitative determination of Rosuvastatin calcium in bulk drug and pharmaceutical formulations.
Stability indicating method and validation for the simultaneous estimation of...SriramNagarajan18
Stability indicating method and validation for the simultaneous estimation of metformin and empagliflozin by using RP-HPLC in a bulk and pharmaceutical dosage forms
Stability indicating method development and validation for the estimation of ...SriramNagarajan18
Stability indicating method development and validation for the estimation of Doxorubicin by using RP-HPLC method in a bulk and pharmaceutical dosage form
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
A comparative study of amlodipine marketed products and their quantitative evaluation by UV – spectrophotometrys
1. Syeda. Z H. H. et al / Int. J. of Farmacia, Vol-1, Issue 1, (July. – Sep. 2015), Pg. 12 - 19
12
International Journal of Farmacia
Journal Home page: www.ijfjournal.com
A comparative study of amlodipine marketed products and their quantitative
evaluation by UV – spectrophotometrys
Syeda Zaineb kubra Hussaini , Syeda Zaineb Humaira Hussaini*
*
Deccan School of Pharmacy, Dar-Us-Salam, Agapura, Nampally, Hyderabad, Telangana State
*
E-mail: humaira_hz@yahoo.com
Abstract
The present work deals with the comparative study of
six different brands of Amlodipine and their
Quantitative Evaluation by UV Spectrophotometry.
The Evaluation of pharmaceutical equivalency of all
the six marketed brands of Amlodipine (5 mg) was
done by Quantitative evaluation, Weight variation
test, Disintegration test, Friability test and Cost
analysis. Objective of the present work is to report
the best drug among the six brands also to give a
suitable and better method for the comparative study.
The Method employs Double Beam UV
spectrophotometer [LAB INDIA-UV 3000+
(version
3.5)]. The selected solvent used was Methanol and
the detection was carried out at a wavelength 237 nm.
The Calibration graph of Amlodipine and the six
brands of Amlodipine were found to be linear with a
Regression Coefficient of 0.98 which falls within the
limits of Beer-Lamberts law. It was found that
Weight Variation Test of Amlodac-5 and Stamlo-5
were not in the acceptance limits and the remaining
four tablets passes the Weight Variation test i.e., they
lie within the acceptance limits of ( 7.5). The
percentage of friability for Amlokind-5 was found to
be 0.649% which was less than 0.8%(normal limits)
and the remaining brands were found out of limits
with little variations. The Disintegration time was
found to be 10 seconds (Fastest release) for
Amlopres-5 and 4.43 minutes (Slowest release) for
Amlodac-5. The tablet Amlokind-5 was found to be
best among all the six brands as it is within the
acceptable limits. And this method of Quantitative
Evaluation was simple, rapid and economical. Hence
it can be successfully utilized for comparative studies
in routine Lab analysis.
Keywords: UV Spectrophotometry, Quantitative
evaluation, Amlodipine
INTRODUCTION
The World Health Organization has identified
Hypertension or High blood pressure as the leading
cause of cardiovascular mortality
Hypertension or high blood pressure
is a chronic medical condition of heart in which
systemic arterial pressure is increased. Normal blood
is below 120/80 mm of Hg. Blood pressure between
120/80 and 139/89 mm of Hg is called Pre-
Hypertension and blood pressure of 140/90 mm of
Hg and above is considered High blood pressure.
Types of hypertension: Hypertension is classified
into two types
Primary or essential hypertension
Secondary hypertension
AIM AND PLAN OF WORK
Aim
The aim of the present work is to do a comparative
study of different brands of Amlodipine and their
quantitative analysis by UV spectrophotometry.
These tests are necessary to ascertain the claim of
pharmaceutical equivalency by most generic
companies.
Plan of work
The experimental work has been planned as follows:
2. Syeda. Z H. H. et al / Int. J. of Farmacia, Vol-1, Issue 1, (July. – Sep. 2015), Pg. 12 - 19
13
Review of literature for Amlodipine regarding its
physical and chemical properties and the
previous analytical methods that were conducted
on this drug forms the basis for quantitative
evaluation of different brands of Amlodipine.
Selection of solvent to be used as diluent.
Choosing the suitable solvent in which drug is
soluble and stable they must be easily available
and economical.
A perfect study of structure of drug and its
physico-chemical properties and review of
literature to select the spectrophotometric
parameters.
Assessment of pharmaceutical equivalency of
different brands of Amlodipine through
quantitative evaluation, and also friability test,
disintegration test, weight variation test and cost
analysis.
MATERIALS AND METHODS
Instruments and chemicals
I. Instruments
S.No Name Model
1. UV-VIS spectrophotometer LAB INDIA-UV 3000+
(version 3.5)
Double beam.
2. UV-software UV WIN-5 spectrophotometer software (version 5.20)
3. Digital balance AFCOSET modern electronic balance (ER-180A)
4. Sonicator Ultra-sonic
5. Friabilator LAB INDIA tablet friability tester- FT 1020
6. Disintegration test apparatus. LAB INDIA DT 1000.
II. Chemicals
S. S.NSS. No. Name Specification
1. METHANOL Grade-AR
2. WATER Double distilled water
3. 0.1N HCL Grade-AR
III. Active pharmaceutical ingredient
S.NO Name Grade/Batch No.
1. AMLODIPINE BESYLATE USP Aurobindo laboratories,
Batch no. :HALC09100010
IV. Marketed formulations
S.NO Brand names Manufacturers Batch no.
1. AMLOKIND-5 Mankind Pharma Ltd. A1AFL121
2. AMLOPIN USV Ltd. 48001347
3. AMCARD Systopic Lab Pvt.Ltd. AY250912
4. STAMLO-5 Dr. Reddy’s Lab.Ltd. E300094
5. AMLODAC-5 Zydus Health Care ZHM2660
6. AMLOPRES-5 Cipla Ltd. A22031
Quantitative evaluation
Calibration of standard amlodipine
Preparation of standard amlodipine
Weigh 50mg of standard amlodipine using
Afcoset modern electronic balance(ER-180A).
Dissolve it in methanol by shaking. The volume
was made up to 1000ml with methanol.
Now the concentration is 1000µg/ml.
Preparations of dilutions of standard drug
Prepare the dilutions from 10µg to 60µg.
3. Syeda. Z H. H. et al / Int. J. of Farmacia, Vol-1, Issue 1, (July. – Sep. 2015), Pg. 12 - 19
14
For preparing 10µg dilution, pipette out 0.1ml
from the above concentration i.e 1000µg/ml and
transfer it in to 10ml volumetric flask and make
up the volume up to the mark.
Similarly, prepare 20µg dilution by pipetting out
0.2ml from the above concentration i.e
1000µg/ml and transfer it in to 10ml volumetric
flask and make up the volume up to the mark.
To prepare 30µg dilution pipette out 0.3ml from
the above concentration i.e 1000µg/ml and
transfer it in to 10ml volumetric flask and make
up the volume up to the mark.
To prepare 40µg dilution pipette out 0.4ml from
the above concentration i.e 1000µg/ml and
transfer it in to 10ml volumetric flask and make
up the volume up to the mark.
To prepare 50µg dilution pipette out 0.5ml from
the above concentration i.e 1000µg/ml and
transfer it in to 10ml volumetric flask and make
up the volume up to the mark.
To prepare 60µg dilution pipette out 0.6ml from
the above concentration i.e 1000µg/ml and
transfer it in to 10ml volumetric flask and make
up the volume up to the mark.
After preparing all the dilutions from 10µg-
60µg, a blank solution is prepared.
Preparation of blank solution
A blank solution was prepared by adding 1ml
methanol and make up the volume to 9ml using
distilled water but without addition of
drug(amlodipine besylate).
Procedure
The absorbance of resulting dilutions were
measured using UV-spectrophotometer at 237nm
wavelength
Keep two blanks in uv/vis-spectrophotometer
(version 3.5) double beam and set it to zero
absorbance.
Now, remove one blank and keep first dilution
sample i.e. 10µg in one cuvette and place it in
the instrument. Check it’s absorbance, it should
be within the limits of regression factor (0.95).
Plot a calibration curve by taking concentration
on x-axis and absorbance on y-axis.
Comparative study of different amlodipine
marketed products with standard amlodipine
Procedure
Weigh the tablets of each brand and note their
individual weights.
Also, take their total weights and average weights.
Triturate 10 tablets of any one brand in a glass
motor to very fine powder.
Then take 10mg of drug from the grinded powder
and add 10ml of methanol to it.
Shake for half-an hour.
Filter the above mixture in to a conical flask by
filtering it through filter paper.
Take 1ml from conical flask and make up to 5ml
with distilled water.
Prepare the blank solution by adding 1ml methanol
and 9ml distilled water. But without addition of drug.
See the absorbance in UV-spectrophotometer by
keeping one blank and one dilution in cuvettes.
Similarly, repeat the same procedure for other
brands and the ℅ drug content was determined
from the absorbance using regression factor
obtained in the calibration curve.
The results obtained are compared with the
standard calibration curve.
Other methods of evaluation of pharmaceutical
equivalency
Cost analysis
Cost analysis is the accumulation, examination and
manipulation of cost data for comparison. Cost
analysis studies which focus on antihypertensive drug
combinations, however, have been scarce.
The objective of the present cost analysis study is to
evaluate and compare the costs of six different
marketed brands of Amlodipine_ Stamlo, Amlodac,
Amlokind, Amlopres, Amcard, Amlopin. The cost of
the marketed drug varies depending upon the cost of
production and the excipients used.
Weight variation test
This is an official test in the in process quality control
of tablets .It give an idea of possible variation within
the same batch by weight variation of tablets.
Frequently for every half an hour corrections are
made during the compression of tablet if necessary.
Any variations in weight of the tablet lead to either
under dose or over dose. This is particularly true
when the drugs are potent or low dose drugs. The
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15
weight variation test is passed if not more than 2
tablets falls outside the range if 20 tablets were taken
and not more than 1 tablet falls outside if only 10
tablets were taken for the test. Improper flow of
granules from the hopper is one of the reason for
weight variation.
Procedure
Take 20 Tablet and weighed individually. Calculate
average weight and compare the individual tablet
weight to the average. The percent differences in
weight variation should be within limits
*The limit should be +or-7.5 .Calculate the average
weight by using following formula
Average weight of tablets = sum of weight of 20 tablets/20
Disintegration test
Disintegration test is a measure of the time required
under a given set of conditions for a group of tablets
to disintegrate into particles which will pass through
a 10 mesh screen. Generally, the test is useful as a
quality assurance tool for conventional dosage forms.
Procedure
The disintegration test is carried out using the
disintegration tester which consists of a basket rack
holding 6 plastic tubes, open at the top and bottom,
the bottom of the tube is covered by a 10-mesh
screen. The basket is immersed in a bath of suitable
liquid held at 37 o
C, preferably in a 1L beaker. For
compressed uncoated tablets, the testing fluid is
usually water at 37 o
C but some monographs direct
that simulated gastric fluid be used.Totest for the
disintegration time, a single tablet is placed in each
tube, and the basket rack is positioned in a 1-L beaker
containing water or simulated gastric fluid, or
stimulated out of the assembly(ie.,0.1N HCl because
stomach pH is 1-3).
Friability Test
Friability is the phenomenon where the surface of the
tablet is damage or shown a site of damage due to
mechanical shock”.
It can also be defined as “Friability is done to
measure the loss of the weight of tablet in the
container or package due the removal of fine particles
from the surface”.
Percentage of friability
The percentage friability of the tablets of a badge can
be found by the following formula:
Percentage Friability = W1 – W2/W1 × 100
Where, W1 = weight of tablets before testing
W2 = weight of tablets after testing.
According to B.P = Percentage of friability should be
not more than 0.8%.
According to U.S.P = Percentage of friability should
be not more than 4%.
RESULTS AND DISCUSSIONS
Quantitative evaluation
Calibration of standard amlodipine
Acceptance criteria
The regression coefficient of the calibration curve
should be 0.988.
Table 1: Calibration of Standard Amlodipine
(Conc. v/s Abs at λ=237nm)
S.No Type Concentration[µg/µl] Absor
bance
1. Standard 10.0000 0.356
2. Standard 20.0000 0.630
3. Standard 30.0000 0.916
4. Standard 40.0000 1.205
5. Standard 50.0000 1.297
1.497
6. Standard 60.0000
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Fig 1: Calibration curve of standard Amlodipine (Conc. v/s Abs at λ=237nm)
Discussion
The Calibration curve obtained was found to be
Linear and the value of Regression coefficient was r
= 0.98, which falls within the limits of Beer-
Lambert’s law and hence the results were found to be
satisfactory.
Comparative study of different marketed
products of amlodipine with standard amlodipine
acceptance criteria
The regression coefficient of the calibration curve
should be 0.988.
Results
Table -2: Calibration of Different Brands of Amlodipine & Determination of Their Unknown Concentration
Fig 2: Calibration curve of different brands of amlodipine & determination of their unknown concentration
0
0.5
1
1.5
2
0 10 20 30 40 50 60 70
Absorbance
concentration[µg/µl]
Concentration vs. Absorbance
Samples Conc. (µg/µl) Absorbance
Stamlo-5 22.892 0.7
Amlodac -5 40.533 1.11
Amlokind-5 11.292 0.442
Amlopres-5 5.601 0.312
Amcard -5 17.114 0.575
Amlopin-5 5.951 0.32
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Discussion
Calibration curve of different brands of Amlodipine
was Linear and Regression coefficient was not more
than r = 0.98 which falls within the limits of Beer –
Lambert’s law.
The concentration of Amlodac-5 was found to be
high, since it is a sustained release film coated tablet
when compared with other brands. Hence the results
were found to be satisfactory.
Other methods of evaluation of pharmaceutical equivalency
Cost analysis
Table-3: Cost Analysis
S. No Brand name Generics Manufacturers Dose Type Price
1. Amlokind-5 Amlodipine Mankind pharma ltd. 5mg Tablet 33/-
2. Amlopin Amlodipine Usv ltd. 5mg Tablet 68/-
3. Amcard Amlodipine Systopic lab pvt. Ltd. 5mg Tablet 50/-
4. Stamlo-5 Amlodipine Dr.reddy’s lab ltd. 5mg Tablet 110/-
5. Amlodac-5 Amlodipine Zydus health care 5mg Tablet 60/-
6. Amlopres-5 Amlodipine Cipla ltd. 5mg Tablet 88/-
Discussion
Stamlo, among all, was found to be available at a
higher price than the other five. It is manufactured by
Dr. Reddy's labs. The cost variation is found to be
due to various excipients like magnesium, calcium &
sodium stearates, wetting agents that are anionic
surfactants are preferred like sodium lauryl sulphate,
suitable anti adherents or glidants are also used like
purified talc.Cost might differ for coated and
uncoated tablets also; as seen in Amlodac. The
excipients used for the film tablet coating are
propylene glycols, titanium dioxide etc.
Weight variation test
Acceptance criteria
The percentage difference in weight variation should
be within limits, the limit should be 7.5. The
weight variation test is passed if not more than 2
tablets falls out of these range.
Results
Calculations of average weights
Table-4: Individual weights & Average weights of all the brands
S.NO Brand A
Stamlo
(grams)
Brand B
Amlodac
(grams)
Brand C
Amlokind
(grams)
Brand D
Amlopres
(grams)
Brand E
Amcard
(grams)
Brand F
Amlopin
(grams)
1. 0.07 0.07 0.15 0.116 0.09 0.203
2. 0.08 0.07 0.15 0.123 0.093 0.196
3. 0.07 0.06 0.15 0.117 0.09 0.194
4. 0.06 0.06 0.15 0.12 0.092 0.198
5. 0.07 0.06 0.15 0.122 0.09 0.202
6. 0.07 0.06 0.15 0.124 0.09 0.194
7. 0.06 0.06 0.16 0.12 0.089 0.197
8. 0.06 0.06 0.15 0.126 0.089 0.196
9. 0.07 0.06 0.16 0.121 0.089 0.195
10. 0.07 0.06 0.15 0.121 0.089 0.198
X 0.68 0.62 1.52 1.21 0.901 1.973
X 0.068 0.062 0.152 0.121 0.0901 0.1973
* =total sum * = arithmetic mean
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18
Discussion
It was found from the above data that Amlodac-5 and
Stamlo-5 are not in the given limits. And the
remaining 4 tablets pass the weight variation test i.e.,
they lie within the acceptance limits.
Disintegrationtest
Acceptance criteria
The limits are 15 mins for uncoated tablet, 1 hr for
coated tablet and 3 mins for dispersable tablet. This
test is not applicable for sustained chewable and
sublingual tablets.
Disintegration time of film coated tablets is 45
mins.
Highly soluble drugs : solubility at 37 0.5 C,
Dose - solubility volume 250ml at PH
: 1.2- 6.8
Rapidly dissolving drugs :
Dissolution 80% in 15 mins at PH
1.2, 4.0, 6.8
Results
Table-5: Disintegration Test
S. no Brandsof amlodipine Disintegration time
1. Amlokind-5 Less than 20 seconds
2. Amcard Less than 20 seconds
3. Amlodac-5 4.43 minutes
4. Stamlo-5 15 seconds
5. Amlopres-5 10 seconds
6. Amlopin 45 seconds
Discussion
From the above experimental data we found that
Amlopress-5 was having fastest disintegration time
of 10 seconds and next was found to be Stamlo-5
with disintegration time of 15 secondsand we
observed that Amlodac -5 was having the slowest
disintegration time because it was a film coated
tablet.
Friability test
Acceptance criteria
Permitted percentage friability should not be more than 0.8%.
Results
Table-6: Friability Test
S.no Brand name Initial weight(grams) Final weight(grams) % friability % loss
1. Stamlo-5 0.069 0.068 1.449% 1.84%
2. Amlopres-5 0.12 0.11 8.33% 0.83%
3. Amlopin 0.196 0.193 1.53% 0.82%
4. Amlodac-5 0.067 0.066 1.492% 1.49%
5. Amlokind-5 0.154 0.153 .0.649% 0.65%
6. Amcard 0.0906 0.089 1.11% 1.77%
Discussion From the above experimental data we conclude that
Amlokind-5 was having the acceptable percent of
friability i.e, 0.649%.
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CONCLUSION
A comparative study of six different brands of
Amlodipine (employed especially for the treatment of
Hypertension and other Coronary artery disease like
Angina pectoris) and their quantitative evaluation by
UV Spectrophotometry was carried out. The six
different brands of Amlodipine 5mg
tablets(Amlokind-5,Amlopin,Amcard,Stamlo-
5,Amlodac5,Amlopres-5) by six pharmaceutical
companies (Mankind Pharma Ltd .,USV
Ltd.,Systopic Lab Pvt Ltd.,Dr.Reddy’s Lab
Ltd.,Zydus Health Care,Cipla Ltd.) respectively were
used. These brands were chosen because they are
readily available in Indian market as well as because
of their cost fidelity.The pharmaceutical equivalency
of six different brands of Amlodipine 5mg tablets
were assessed through the quantitative
evaluation,weight variation est, friability test,
disintegration test .In the current study methanol is
used as solvent and the detection was carried out at a
wavelength 237 nm in a UV Spectrophotometer .The
calibration graph of standard amlodipine and six
different brands of amlodipine was found to be linear
in the concentration range of 10-60µg/ml with
regression coefficient value of 0.98 .It was found that
Weight Variation Test of Amlodac-5 and Stamlo-5
were not in the acceptance limits and the remaining
four tablets passes the Weight Variation Test i.e.,
they lie within the acceptance limits of ( 7.5). The
percentage of friability for Amlokind-5 was found to
be 0.649% which was less than 0.8% (normal limits)
and the remaining brands were found out of limits
with little variations. The disintegration time was
found to be 10 seconds (Fastest release) for
Amlopres-5 and 4.43 minutes (Slowest release)for
Amlodac-5.The best tablet among all the six brands
was Amlokind-5(Mankind Pharmaceuticals) as its
concentration falls within the acceptable limits of
Beer-Lamberts law(10-60µg/ml),and it also passes
the Weight variation test (with
limits 7.5),Disintegration test(with <20 seconds) and
Friability test with 0.649%.Based on cost analysis
data amlokind-5 has the lowest price of (Rs 33/-)
which makes it cost effective and preferable in
management of Hypertension. This method is simple,
rapid and Economical. Hence it can be easily and
conveniently adopted in routine lab analysis for
Comparative Studies.
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