Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF AMLODIPINE BESYLATE AND TELMISARTAN IN BULK AND PHARMACEUTICAL DOSAGE FORM

P. Surya Prakash Raj*, P.Venkateswarao and B.Thangabalan

Abstract

A simple, validated RP-HPLC method for the simultaneous estimation of Amlodipine Besylate and Telmisartan in pharmaceutical dosage form and bulk was developed for routine analysis. This method was developed by selecting Chromosil C18 (250×4.6mm column as stationary phase and acetonitrile: methanol (50: 50v/v) as mobile phase. Flow rate of mobile phase was maintained at 1 ml/min at ambient temperature throughout the experiment. Quantification was achieved with ultraviolet detection at 240 nm. The retention times of Amlodipine Besylate and Telmisartan were found as 5.2 min and 2.5 min respectively. The detector response was linear in the concentration range of 5- 80 μg/ml and 40-640 μg/ml of Amlodipine Besylate and Telmisartan respectively. The regression coefficient was 0.999 for both drugs. From recovery studies we concluded that the drugs have no interference with any excepients in the formulation. This method has been validated according to ICH guidelines and shown to be specific, sensitive, precise, accurate, rugged and robust. Hence, this method can be applied for routine quality control analysis of Amlodipine Besylate and Telmisartan in dosage form as well as in bulk drug.

Keywords: Chromosil, Amlodipine Besylate and Telmisartan.