Method development and validation for simultaneous estimation of amlodipine and Olmesartan in combined tablet dosage form by using RP-HPLC

Abstract

The objective of the current study was to develop a simple, accurate, precise and rapid RP-HPLC method with subsequently validate as per ICH guidelines for the determination of Amlodipine (AML) and Olmesartan (OLM) using mobile phase [mixture of acetonitrile and methanol in the ratio of 60:40] as the solvent. The proposed method involves the measurement of Retention time at selected analytical wavelength. 260.0 nm was selected as the analytical wavelength. The retention time of AML and OLM was found to be 3.351 and 1.833 respectively. The linearity of the proposed method was investigated in the range of 5-25 µg/ml (r2 = 0.9999) for AML and 10-50 µg/ml (r2 = 0.9998) for OLM respectively. The method was statistically validated for its linearity, accuracy and precision. Both inter-day and intra-day variation was found to be showing less % RSD (Relative Standard Deviation) value indicating high grade of precision of the method.