This document describes the development of a RP-HPLC method for the simultaneous estimation of Bendamustine Hydrochrolide and Omeprazole in an injection formulation. The objective is to develop a simple, sensitive, economical, precise and accurate chromatographic method. Literature reviews found no existing methods for simultaneous estimation of these two drugs. The plan of work involves literature review, selection of drugs, selection of mobile phase, optimization of chromatographic conditions, and validation of the method through accuracy, precision, specificity, linearity, LOD/LOQ, ruggedness and robustness testing.
An emerging way of estimation of Olmesartan medoxomil & Hydrochlorothiazide i...Priyanka Bose
An emerging way of estimation of Olmesartan medoxomil & Hydrochlorothiazide in Bulk & Combined tablet dosage form by Absorbance Correction Method using methanol as solvent system. It is cost effective, highly precised method for estimation.
An emerging way of estimation of Olmesartan medoxomil & Hydrochlorothiazide i...Priyanka Bose
An emerging way of estimation of Olmesartan medoxomil & Hydrochlorothiazide in Bulk & Combined tablet dosage form by Absorbance Correction Method using methanol as solvent system. It is cost effective, highly precised method for estimation.
Analytical Method Development and Validation of Metformin Hydrochloride by us...ijtsrd
A simple and reproducible method was developed for Metformin MET by Reverse Phase High Performance Liquid Chromatography RP HPLC . Metformin was separated on C18 column 4.6x250mm, particle size 5µm , using combination of phosphate buffer with pH of 3.0 and Methanol at the UV detection of 238nm. Isocratic elution of phosphate buffer with pH of 3.0 and Methanol was used as a mobile phase with various ratios and flow rates, eventually 30 70 v v phosphate buffer with pH of 3.0 and Methanol was being set with the flow rate of 1mL min. The statistical validation parameters such as linearity, accuracy, precision, inter day and intra day variation were checked, assay studies of Metformin were within 98 to 102 indicating that the proposed method can be adoptable for quality control analysis of Metformin. Mr. Nilesh Nikam | Dr. Avish Maru | Dr. Anil Jadhav | Dr. Prashant Malpure ""Analytical Method Development and Validation of Metformin Hydrochloride by using RP-HPLC with ICH Guidelines"" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-3 | Issue-3 , April 2019, URL: https://www.ijtsrd.com/papers/ijtsrd22812.pdf
Paper URL: https://www.ijtsrd.com/pharmacy/analytical-chemistry/22812/analytical-method-development-and-validation-of-metformin-hydrochloride-by-using-rp-hplc-with-ich-guidelines/mr-nilesh-nikam
A Simple Rp- HPLC Method for Simultaneous Estimation of Six Cardiovascular Dr...iosrjce
A simple, convenient Rp-HPLC method has been developed and validated for the simultaneous
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was 450C and injection volume was 20µl. The method was validated for precision, linearity and accuracy. The
% RSD for all the drugs was found to be less than 2 %. The correlation coefficient (r2
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for all drugs. The mean percent recovery of the drugs from tablet placebo at 50%, 100% and 150% were within
limits. The marketed formulations of the drugs were analyzed and the mean assay results were found to be
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Analytical Method Development and Validation of Metformin Hydrochloride by us...ijtsrd
A simple and reproducible method was developed for Metformin MET by Reverse Phase High Performance Liquid Chromatography RP HPLC . Metformin was separated on C18 column 4.6x250mm, particle size 5µm , using combination of phosphate buffer with pH of 3.0 and Methanol at the UV detection of 238nm. Isocratic elution of phosphate buffer with pH of 3.0 and Methanol was used as a mobile phase with various ratios and flow rates, eventually 30 70 v v phosphate buffer with pH of 3.0 and Methanol was being set with the flow rate of 1mL min. The statistical validation parameters such as linearity, accuracy, precision, inter day and intra day variation were checked, assay studies of Metformin were within 98 to 102 indicating that the proposed method can be adoptable for quality control analysis of Metformin. Mr. Nilesh Nikam | Dr. Avish Maru | Dr. Anil Jadhav | Dr. Prashant Malpure ""Analytical Method Development and Validation of Metformin Hydrochloride by using RP-HPLC with ICH Guidelines"" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-3 | Issue-3 , April 2019, URL: https://www.ijtsrd.com/papers/ijtsrd22812.pdf
Paper URL: https://www.ijtsrd.com/pharmacy/analytical-chemistry/22812/analytical-method-development-and-validation-of-metformin-hydrochloride-by-using-rp-hplc-with-ich-guidelines/mr-nilesh-nikam
A Simple Rp- HPLC Method for Simultaneous Estimation of Six Cardiovascular Dr...iosrjce
A simple, convenient Rp-HPLC method has been developed and validated for the simultaneous
estimation of Metolazone, Indapamide, Nebivolol, Rosuvastatin, Olmesartan and Spironolactone. The column
used was an Inertsil ODS 3 V column of 250 mm length × 4.6 mm ID, with 3 micron particle size of adsorbent.
Separation was achieved using isocratic elution in a buffer-acetonitrile-methanol mobile phase at a flow rate of
1.2 ml/min. The detection was performed at wavelength of 225 nm using a UV detector. The column temperature
was 450C and injection volume was 20µl. The method was validated for precision, linearity and accuracy. The
% RSD for all the drugs was found to be less than 2 %. The correlation coefficient (r2
) was not less than 0.999
for all drugs. The mean percent recovery of the drugs from tablet placebo at 50%, 100% and 150% were within
limits. The marketed formulations of the drugs were analyzed and the mean assay results were found to be
within limits. The developed method can thus be employed for routine simultaneous analysis of Metolazone,
Indapamide, Nebivolol, Rosuvastatin, Olmesartan and Spironolactone in bulk and in their marketed
formulations
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LC-MS/MS method for the quantification of carbinoxamine in human plasmaIOSR Journals
A simple, reverse-phase high performance liquid chromatographic method with mass spectrometric detection (HPLC-MS/MS) was developed for determination of carbinoxamine in human plasma using pargeverine HCl as an internal standard. The procedure involves a simple protein precipitation technique using BDS HYPERSIL C8 (100 x 4.6mm) column. The mobile phase used was acetonitrile: buffer (25mm ammonium formate solution) (80:20). Precipitation was done using acetonitrile and detection was done in MRM mode, using an Electro Spray positive ionization. The ion transition monitored was (m/z) carbinoxamine (Q1 Mass: 291.2; Q3 Mass: 167.1), Internal standard (Q1 Mass: 338.1; Q3 Mass; 167.0). The retention time of carbinoxamine and internal Standard were 1.61 and 1.75 respectively. Method was evaluated in terms of linearity, accuracy, precision, recovery, sensitivity. The simple extraction procedure and short chromatographic runtime make the method suitable for therapeutic drug monitoring studies.
Method Development and Validation for Simultaneous Estimation of Dasatinib an...YogeshIJTSRD
The present study describes a newly developed, optimized and validated isocratic RP HPLC method for the separation of two tyrosine kinase inhibitors Dasatinib DST and Erlotinib ERT with Methyl paraben MPB as internal standard IS , in bulk and pharmaceutical formulations with the aid of Chemometrics, multi criteria decision making MCDM approach. The separation was achieved by using Phenomenex Enable C18 column 15×4.6 mm id, 5µm particle size and PDA UV detection at 277nm.The range of independent variables used for the optimization were MeOH 60 70 , pH 2 2.5 and flow rate 0.3 0.8ml min. The influence of these independent variables on the output responses capacity factor of the first peak k1 , resolution Rs and separation a of the second peak and retention time tR3 were evaluated. Using this strategy, mathematical model was defined, and response surface were derived for the separation. The coefficients of determination R2 were more than 0.9258 for all the models. The four responses were simultaneously optimized by using Derringers desirability functions and MCDM approach. Optimum conditions chosen for assay were MeOH, 0.01mM KH2PO4 pH 2.5±0.5 adjusted with diluted orthophosphoric acid solution 68.03 31.97v v and flow rate of 0.8 mL min. Peak area ratio of the analyte and internal standard was used for the quantification of pharmaceutical formulation samples. Total chromatographic analysis time per sample was approximately 9.0 min with DST, MPB IS and ERT eluting with retention times of 2.7, 3.2, and 6.0 minutes respectively. The optimized assay condition was validated as per ICH guidelines and applied for the quantitative analysis Sprycel DST tablet and Tarceva ERT capsule. Dara. Varun | Kumaraswamy. Gandla | R. Lalitha | M. Muralikrishna "Method Development and Validation for Simultaneous Estimation of Dasatinib and Erlotinib by Using RP-HPLC in Pharmaceutical Dosage Form" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-3 , April 2021, URL: https://www.ijtsrd.com/papers/ijtsrd41117.pdf Paper URL: https://www.ijtsrd.com/pharmacy/other/41117/method-development-and-validation-for-simultaneous-estimation-of-dasatinib-and-erlotinib-by-using-rphplc-in-pharmaceutical-dosage-form/dara-varun
A Simple and Validated RP-HPLC Method for the Estimation of Methylcobalamin i...
Sampath
1. Development of RP-HPLC method for
Simultaneous estimation of Bendamustine
Hydrochrolide and Omeprazole in Injection
formulation
Under the esteemed guidance of
Sri B. Thangabalan M.pharm, (Ph.d)
Presented by
K. Sampath Kumar
Y11MPH18060
SIMS COLLEGE OF PHARMACY
1 GUNTUR.
2. Aim & Objective
The literature survey indicates that there are no methods
reported for the simultaneous estimation of Bendamustine
Hydrochrolide and Omeprazole by RP – HPLC.
The present work is undertaken with an objective to develop
& validate a simple, sensitive, economical , precise & accurate
chromatographic method by HPLC.
3. Bendamustine Hydrochloride:
Description: white microcrystalline powder
Mol. Formula:C16H21Cl2N3O2
Mol. Weight: 358.262gm/mol
Iupac Name: (4-{5-[bis-(2-chloroethyl) amino]-1-methyl-
1Hbenzimidazol-2-yl} butanoic acid)
Cl-H2C-H2C
N N
Cl-H2C-H2C
.
(CH2)3-COOH HCl
N
CH3
5. UV method:
1. M. Mathrusri Annapurna et.al Derivative Spectrophotometric Methods for the
Determination of Bendamustine Hydrochloride
2. M. Mathrusri Annapurna et.al New analytical methods for the determination of
Bendamustine hydrochloride: An anti-neoplastic drug
3. D.Kumaraswamy Statistical assurance of process validation by analytical method
development and validation for omeprazole capsules and blend.
4. Satish d. Bhuva, mehul m. Patel spectrophotometric simultaneous estimation of
omeprazole and cinitapride in bulk and formulation
5. Nayan M Jagani et.al Development and Validation of Dual Wavelength Method
For Simultaneous Estimation of Omeprazole and Cinitapride in Combined
Capsule Dosage Form.
6. Y.G. Makani et.al development and validation of first order derivative
Spectrophotometric method for simultaneous estimation of Omeprazole and
cinitapride in pharmaceutical dosage form
6. HPLC:
7. Mathrusri Annapurna M. et.al Stability-Indicating Liquid Chromatographic
Method for the Determination of Bendamustine Hydrochloride in
Parenterals
8. E. Sasi Kiran Goud et. al Development and validation of RP-HPLC
method for determination of related substances of bendamustine
hydrochloride in bulk drug
9. Kalakonda Sri Nataraj et.al Development and validation of RP-HPLC
method for the estimation of omeprazole in bulk and capsule dosage forms
10. S. S. Pujeri et.al Development and Validation of LC Method for the Assay
of Omeprazole Enantiomers in Pharmaceutical Formulations
7. Plan of Work
1. Literature Survey
2. Selection of multi-component formulation
3. Procurement of selected drug for study
4. Selection of mobile phase
5. Optimization of chromatographic conditions
A. selection of column
B. selection of column temperature
C. selection of flow rate
D. fixing of injection volume
E. fixing of detection wave length
6. Validation
i. Accuracy iv. Linearity
ii. Precision v. LOD/LOQ
iii. Specificity vi. Ruggedness
vii. Robustness