A Stability Indicating Method Development of Atorvastatin Calcium and Amlodipine Besylate in Combined Tablet Dosage Forms by RPHPLC

Abstract

A new stability indicating RP-HPLC method was developed for simultaneous estimation of atorvastatin and amlodipine in combined tablet formulations. Chromatography was carried out on a Kromasil C18 HPLC Column (250 x 4.6 mm; 5μm) eluting with a mobile phase consisting of a 60:40 v/v mixture of 0.1% orthophosphoric acid in water and acetonitrile (ACN) at a flow rate of 1.0 mL/ minute. The detection wavelength was set at 240 nm. Accuracy was assessed by using standard addition method. The developed HPLC method was validated with respect to precision, specificity, accuracy, linearity and robustness. Forced degradation studies on the formulation were conducted by adopting the proposed method to assess the stability of the analytes under acid, base, peroxide, thermal and photolytic conditions and suitability of the method to resolve the degradation products. © 2020 iGlobal Research and Publishing Foundation. All rights reserved. Cite this article as: Indira, A.; Sreedhar, N.Y. A stability indicating method development of atorvastatin calcium and amlodipine besylate in combined tablet dosage forms by RP-HPLC. Indo Global J. Pharm. Sci., 2020; 10(1): 79-84. DOI: http://doi.org/10.35652/IGJPS.2020.10111 . Indo Global Journal of Pharmaceutical Sciences, 2020; 10(1): 79-84 80 atorvastatin and amlodipine in bulk and pharmaceutical dosage forms. Fig. 1: Structure of a) Atorvastatin b) Amlodipine MATERIALS AND METHODS Chemicals and Reagents Amlodipine besylate and Atorvastatin calcium were obtained as gift samples from Mylan Laboratories Ltd., Hyderabad. Methanol AR grade, HCl, NaOH and hydrogen peroxide were procured from SD Fine Chem limited, Mumbai. HPLC water and Methanol were purchased from Merck specialties private limited, Mumbai. The combination tablets AMTR 10 were purchased from local pharmacy.