Analytical Method Development and Validation for the Simultaneous Estimation of Azelnidipine and Telmisartan by RP-HPLC in Bulk and Tablet Dosage Forms

Abstract

An accurate, precise and reproducible RP-HPLC method was developed for the simultaneous quantitative determination of Azelnidipine and Telmisartan in tablet dosage forms. Agilent (S.K) Gradient System UV Detector and C18 column with 250mm x 4.6mm i.d and 5μm particle size Acetonitrile: ph Buffer (80:20v/v) pH 3 was used as the mobile phase for the method. The detection wavelength was 237nm and flow rate was 0.9 ml/min. In the developed method, the retention time of Azelnidipine and Telmisartan were found to be 4.77 min and 11.97min. The developed method was validated according to the ICH guidelines. The linearity, precision, range, robustness was within the limits as specified by the ICH guidelines. Hence the method was found to be simple, accurate, precise, economic and reproducible. The developed method was validated according to the ICH guidelines. In this methods linearity, precision, range, robustness were observed. The method was found to be simple, accurate, precise, economic and reproducible. So the proposed methods can be used for the routine quality control analysis of AZN and TMZ in bulk drug as well as in formulations.