METHOD DEVELOPMENT AND VALIDATION OF CLEANING PROCEDURE FOR THE RESIDUAL DETERMINATION OF FLUNIXIN MEGLUMINE IN BULK DRUG MANUFACTURING OF ACTIVE PHARMACEUTICALS INGREDIENT BY REVERSE PHASE HIGH PRESSURE LIQUID CHROMATOGRAPHY

2017 ◽  
pp. 1301-1314
Author(s):  
Dr. K. Basavaiah
Keyword(s):  
High Pressure ◽  
Method Development ◽  
Reverse Phase ◽  
Cleaning Procedure ◽  
Flunixin Meglumine ◽  
Drug Manufacturing ◽  
Method Development And Validation ◽  
Bulk Drug ◽  
Development And Validation

scholarly journals METHOD DEVELOPMENT AND VALIDATION OF EPROSARTAN MESYLATE AND ITS IMPURITIES USING REVERSE PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

2016 ◽  
Vol 8 (4) ◽  
pp. 49 ◽  
Author(s):  
O. S. S. Chandana ◽  
D. Sathis Kumar ◽  
R. Ravichandra Babu
Keyword(s):  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Reverse Phase ◽  
Related Substances ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
The Mean ◽  
Development And Validation

Objective: Our main objective is to develop an accurate and precise RP-HPLC method for the determination of Eprosartan Mesylate and its impurities. Methods: A Develosil ODS UG-5; (150 × 4.6) mm; 5 µm column was used for the Separation of drugs by a mobile phase consisting of Buffer and Acetonitrile mixture in the gradient proportion. The flow rate maintained was 0.8 ml/min and the wavelength used for detection was 235 nm.Results: The linearity was observed in the range of 0.025-50µg/ml of spiked impurities in Eprosartan Mesylate, impurity 1 and impurity 2 with a correlation coefficient of 0.99927, 0.99910 and 0.99934 respectively. The mean percentage recoveries for LOQ, 50%, 80%, 100%, 150% and 200% accuracy were found to be 101.5±1.51, 107.0±1.7, 104.6±0.4, 102.8±0.36, 101.7±0.26 and 101.3±0.15 respectively for impurities in Eprosartan Mesylate, impurity 1 and impurity 2. Linearity, accuracy, precision and robustness parameters for the suggested method were estimated for validation.Conclusion: The developed method is uncomplicated, accurate, sensitive and precise for the determination of related substances in the Eprosartan Mesylate. The satisfying % recoveries and low % RSD Values confirmed the suitability of the developed method for the usual analysis of Eprosartan mesylate in pharmaceuticals.

scholarly journals METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION OF AZELNIDIPINE AND TELMISARTAN IN TABLET DOSAGE FORM BY RP- HPLC

2021 ◽  
Vol 6 (10) ◽  
pp. 26-36
Author(s):  
Silky Agrawal ◽  
Tahir Nizami
Keyword(s):  
Simultaneous Determination ◽  
Method Development ◽  
Quality Analysis ◽  
Potassium Dihydrogen ◽  
Method Development And Validation ◽  
Bulk Drug ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Potassium Dihydrogen Orthophosphate

A simple, accurate and precise method for the simultaneous determination of azelnidipine and telmisartan in bulk drug and pharmaceutical dosage has been developed by RPHPLC method. Separation was performed on a Hyperchrom ODS C18 HPLC Column (250*4.6mm) column and Buffer 0.05M Potassium dihydrogen orthophosphate (KH₂PO₄) Buffer (pH-4.0): Methanol (60:40) as a mobile phase, at a flow rate 1ml/min and UV detection wavelength 215 nm. The calibration of the method was performed by concentration range of 20-60μg/ml for telmisartan and 40-120 μg/ml for azelndipine. The validation of proposed method was carried out for accuracy, precision, ruggedness, specificity for both alzenidipine and telmisartan the method can be used for routine quality analysis of titled drug in tablet formulation.

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