DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF RELATED SUBSTANCES OF S (-) AMLODIPINE AND TELMISARTAN IN FIXED DOSE COMBINATION TABLET DOSAGE FORM

A simple, sensitive and specific reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the quantification of related impurities of S(-) Amlodipine (AML) and Telmisartan (TEL) in fixed dose combination tablet dosage form. The chromatographic separation employs gradient elution using a Poroshell 120, EC-C18 (4.6 mm X 150mm, 2.7?m) column. Mobile phase consisting of solvent A (solution containing pH 4.0 ammonium acetate buffer and 0.05%v/v formic acid in Acetonitrile in the ratio of 80:20v/v) and solvent B (solution containing pH 4.0 ammonium acetate buffer and 0.05%v/v formic acid in Acetonitrile in the ratio of 20:80v/v) delivered at a flow rate of 1.0 mL min−1. The analytes were detected and quantified at 254 nm using UV detector. The method was validated as per ICH guidelines, demonstrating to be accurate and precise within the corresponding linear range of known impurities of S (-) Amlodipine and Telmisartan. This method can be used for the estimation of related substances of S (-) Amlodipine and Telmisartan in fixed dose combination tablet dosage form