Abstract

DEVELOPMENT AND VALIDATION OF REVERSED-PHASE HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ATORVASTATIN CALCIUM AND TELMISARTAN IN PHARMACEUTICAL DOSAGE FORM

Razia Sulthana*, J.N.Suresh Kumar, N.Sai Priyanka, Ajay Babu .Ch, N.Sambasivanaik

ABSTRACT

A simple, precise and accurate reversed-phase liquid chromatographic method has been developed for the simultaneous estimation of atorvastatin calcium and telmisartan in tablet formulations. The chromatographic separation was achieved on (C18, 250mm x 4.6mm, 5μ) analytical column. A mixture of ammonium acetate (0.02M, pH 4.0 adjusted with glacial acetic acid) and acetonitrile in ratio (40:60 v/v) at flow rate of 1.0ml/min and detector wavelength 254 nm. The retention time of atorvastatin calcium and telmisartan was found to be 4.6 and 6.1 minutes respectively. The validation of the proposed method was carried out for its specificity, linearity, accuracy, precision, limit of detection and quantification for both atorvastatin calcium and telmisartan. The developed method can be used for routine quality analysis of titled drugs in combination in tablet formulation.

Keywords: Telmisartan, Atorvastatin calcium, RP-HPLC, validation, assay.