Abstract

VALIDATED U.V. SPECTROPHOTOMETRIC METHOD OF SIMULTANEOUS ESTIMATION OF AMLODIPINE BESYLATE AND TELMISARTAN IN BULK AND IN TABLET DOSAGE FORM

Sandeep Singh, Marina Koland

Abstract

A simple, accurate, rapid and precise simultaneous analytical method has been developed for simultaneous determination of Amlodipine Besylate and Telmisartan in bulk and in their combined tablet dosage form. Simulated gastric fluid of pH 1.2 was used as medium. Absorption Ration method was developed and is validated statistically as per ICH guidelines. The absorptions were observed at 291nm and 324nm which were selected based on overlap spectra of Amlodipine Besylate and Telmisartan. Linearity was observed by linear regression equation method for both drugs in different concentration range. The Correlation coefficient of these drugs was found to be close to 1.00, indicating good linearity. The % R.S.D. were found to be less than 2 % as required by ICH guidelines, which indicates the validity of methods. Statistical analysis proves that the method is reliable, sensitive, reproducible and selective for the simultaneous estimation of Amlodipine Besylate and Telmisartan.

Keywords: Absoption Ratio method, Amlodipine Besylate, Telmisartan, Simulated Gastric Fluid, etc.