Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF TAMSULOSIN HCL AND TOLTERODINE TARTRATE IN COMBINED PHARMACEUTICAL DOSAGE FORMS

Kiranmai M.*, Anusha K., Rubina Kauser and Prathyusha J.

Abstract

A simple and selective RP-HPLC method was developed for the simultaneous determination of Tamsulosin hydrochloride and Tolterodine tartrate tablet dosage forms. Chromatographic separation was achieved on an Inertsil ODS C18 column (4.6 mm × 250 mm, 5 µm) using mobile phase consisting of a mixture of phosphate buffer (KH2PO4) and Acetonitrile (CH3CN) in the ratio 50:50 v/v, with detection of 214 nm. Retention time was estimated to be 2.81 min and 4.28 min for Tamsulosin Hydrochloride & Tolterodine tartrate respectively. Accuracy was found to be 100.46% and 99.6% for Tamsulosin HCL and Tolterodine tartrate respectively. The linearity was observed over a range of 0.25-0.75µg/ml for Tamsulosin HCl and 2.5-7.5µg/ml for Tolterodine tartrate. In precision relative standard deviation values for both was found to be less than 2.0%. The designed method was found to be simple, specific, accurate, linear and precise. It can be used for regular analysis for the simultaneous estimation of Tamsulosin hydrochloride and Tolterodine tartrate tablet dosage forms.

Keywords: Tamsulosin HCl, Tolterodine tartrate, RP-HPLC, Method development, Validation.