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VOL. 5, ISSUE 2 (2020)
Analytical method development and validation with degradation protocol for amlodipine and cilazapril
Authors
Prashant Kumar Katiyar, Dr. R. S. Ghosh
Abstract
Objective: To develop and validate RP-HPLC method that will be helpful in the estimation of drugs in the dosage form in an economic way and on a routine basis for Amlodipine and Cilazapril. Method: Chromatographic separation was achieved with a Shimadzu’s high-performance liquid chromatography C18 column (150X4.6 mm, 5mm) with a mobile phase Acetonitrile: potassium dihydrogen phosphate buffer: Methanol in a ration 50:20:25 v/v/v with a buffer having pH 6.8. The flow rate was set at 1ml/min and the detection wavelength was 365 nm for Amlodipine and 254 nm for Cilazapril. This developed chromatographic method gave well-resolved symmetric peaks. Results: The retention time of Amlodipine was found to be 2.81min and that of Cilazapril was around 4.77 min. The plate count of Amlodipine was in range and was found to be 4744 and Cilazapril has 4477 with tailing factor of 1.26 and 1.23 for Amlodipine and Cilazapril respectively. The method was linear in a range of 5 to 25μg/ ml for Amlodipine and 2 to 10 μg/ ml for Cilazapril through UV spectroscopy with regression 0.9918 and 0.996, respectively. Conclusion: Based on standard calibration curve, the LOD and LOQ values were calculated. The LOD and LOQ for Amlodipine were found to be 0.1711 ðœ‡g/mL and 0.4998 ðœ‡g/mL and for Cilazapril it was found to be 0.4891 ðœ‡g/mL and 0.4049 ðœ‡g/Ml. The sample recoveries were in good agreement with the respective formulation, which suggested non-interference from formulation additives in the estimation.
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Pages:31-36
How to cite this article:
Prashant Kumar Katiyar, Dr. R. S. Ghosh "Analytical method development and validation with degradation protocol for amlodipine and cilazapril". International Journal of Research in Pharmacy and
Pharmaceutical Sciences, Vol 5, Issue 2, 2020, Pages 31-36
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