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Development and validation of RP-HPLCmethod for simultaneous estimation of losartan potassiumand amlodipine besylate in synthetic mixture and pharmaceutical dosage form

Ramesh Sawant, Kalyani Jadhav, Ajay Shirsat

A precise, simple, accurate, reproducible, rapid, and economic RP-HPLC method has been developed for simultaneous estimation of losartan potassium and amlodipine besylate in synthetic mixture and pharmaceutical dosage form. The components were well separated using HibarR 250-4.6 PurospherR STAR RP-C18 (5µm) column using 0.1% triethylamine in water: methanol (32:68 v/v) PH of which was adjusted to 3.8 with orthophosphoric acid as mobile phase at a flow rate of 1.0 ml/min. The wavelength was selected at 235 nm using UV detector. The retention time of losartan potassium and amlodipine besylate was found to be 7.650 and 6.417 respectively. The method was validated for system suitability, specificity, linearity, accuracy, precision, ruggedness and robustness as per ICH guidelines and the results were found to be within the limits.