VALIDATED RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF LOSARTAN AND AMLODIPINE IN BULK AND TABLET DOSAGE FORM

A simple, precise, and validated Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method was developed for the simultaneous estimation of Losartan and Amlodipine in bulk and tablet dosage forms. The chromatographic analysis was carried out using a Develosil C18 column (4.6 mm × 250 mm, 5 µm) maintained at ambient temperature. The mobile phase comprised Acetonitrile and Acetate buffer (pH 4.3) in the ratio of 35:65% v/v, delivered at a flow rate of 1 mL/min. Detection was performed at a wavelength of 238 nm, with an injection volume of 20 µL and a run time of 6 minutes. The method produced well-resolved peaks for both Losartan and Amlodipine with consistent retention times and no interference from excipients. It was validated in accordance with ICH Q2(R1) guidelines, demonstrating excellent linearity, precision, accuracy, specificity, and robustness. The results confirm that this RP-HPLC method is suitable for the routine quality control of Losartan and Amlodipine in combined pharmaceutical dosage forms. Keywords: RP-HPLC, Losartan, Amlodipine, Develosil C18 column, linearity, accuracy.