Method development and validation of telmisartan and amlodipine besylate by RP-HPLC in Tablet Dosage form

Author Details
MD. Ashraf Basha*, K. Mangamma, G. Mani kumar 
Dept of Pharmaceutical Analysis and Quality Assurance, JNTU School of Pharmaceutical Sciences, Kakinada

Abstract
A simple, precise, accurate and rapid reverse phase high performance liquid chromatographic method had been developed for simultaneous estimation of Telmisartan and Amlodipine Besylate in tablet dosage form. SymmetryC18 4.6 x 250mm, 5m particle size was used. The method was carried out in gradient program using mobile phase, 0.02M Potassium dihydrogen orthophosphate: acetonitrile (30:70 v/v) adjusted to pH-5 using dilute ortho phosphoric acid. Flow rate was adjusted to 1.0ml/min and effluents were monitored at 245nm. The retention time obtained for Amlodipine Besylate and Telmisartan was 2.325 and 3.523 min respectively. The calibration curves were linear in the concentration range of 32-96μg/ml for Telmisartan and 4-12μg/ml for Amlodipine. The developed method was validated in accordance to ICH guidelines.
Keywords: Telmisartan, Amlodipine besylate, Acetonitrile, RP-HPLC