Abstract

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

Sathish Kumar Konidala*, Santosh Kumar Vobbilireddi, Risy NamrathaJammulamudi, Sujana K and Dr. A. Prameela Rani

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 ACN: MeOH: water (65: 30: 5 v/v/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 (DAD) detection at 240 nm. The retention times of Amlodipine Besylate and Telmisartan were found as 4.56 min and 6.59 min respectively. The detector response was linear in the concentration range of 2- 20 μg/ml and 16-160 μg/ml, has regression coefficients 0.998 and 0.999 for Amlodipine Besylate and Telmisartan respectively. From recovery studies we concluded that the recovery of amlodipine besylate and telmisartan has 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 of Amlodipine Besylate and Telmisartan in dosage forms as well as in bulk drug.

Keywords: Amlodipine Besylate, Telmisartan, RP-HPLC, Twynsta tablets.