Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF BENIDIPINE HYDROCHLORIDE AND TELMISARTAN IN TABLET

Payal G. Jain*, Ankit B. Chaudhary and Shweta M. Bhadani

ABSTRACT

A specific, precise and accurate RP-HPLC method was developed for the simultaneous estimation of Benidipine hydrochloride and Telmisartan in tablet. The separation was carried out using Inertsil ODS C18 column (150 x 4.6 mm, 5 μm), mixture of 0.05M Potassium Dihydrogen Phosphate Buffer (pH - 4.5 adjusted with 1% OPA) and Acetonitrile (40: 60% v/v) as a mobile phase. The flow rate was adjusted to 1 mL/min and effluent was monitored at 267 nm by used PDA detector. The retention times of Benidipine hydrochloride and Telmisartan were found to be 2.977 and 5.167 respectively. The different analytical parameters such as specificity, linearity, LOD, LOQ, precision, accuracy, robustness were determined according to ICH guidelines. The method was linear over the range 2 - 6 μg/mL and 20 - 60 μg/mL for Benidipine hydrochloride and Telmisartan. The % recoveries of Benidipine hydrochloride and Telmisartan were found to be 100.46% - 101.17% and 100.20% - 100.38% respectively. The method was found to be specific, precise and accurate and robust during study. The proposed method enables rapid quantification and simultaneous analysis of drug from commercial formulation without any interference of excipient. So, the method can be used for routine analysis of Benidipine hydrochloride and Telmisartan in tablet.

Keywords: Benidipine hydrochloride, Telmisartan, RP-HPLC, Validation.