DETERMINATION OF TELMISARTAN AND FORCED DEGRADATION BEHAVIOR BY RP-HPLC IN TABLET DOSAGE FORM

Abstract

A simple, rapid, precise, sensitive and reproducible reverse phase high performance liquid chromatographic (RP-HPLC) method for determination of Telmisartan (TELM) in tablet dosage form was developed and validated. Chromatographic separation was achieved on a 250 4.6 mm, 5?, Waters symmetry column in gradient mode, with mobile phase consisting of a mixture of solution (10 mM potassium dihydrogen phosphate, pH 3.5 0.01): acetonitrile (64:40) was used. The quantitation performed at flow rate of 1.0 mL/min at 230 nm and run time was 12 min. The analytical method was validated as per ICH guideline for linearity, accuracy, precision, specificity, limit of detection, limit of quantification, robustness and stability and method can be extended to the analysis of TELM in tablet formulations. The relative standard deviation values for precision was less than 2%, and % recovery was greater than 98% for TELM. The drug undergoes oxidative degradation, thermal degradation and in alkali medium.