Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF TAMSULOSIN AND TOLTERODINE IN CAPSULE DOSAGE FORM BY RP-HPLC

Anjali Bakshi*, Sarika Parakala, Shweta Bhutada and Dr. M. Bhagvan Raju

ABSTRACT

A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the simultaneous determination Tamsulosin hydrochloride and Tolterodine tartrate in capsule dosage form. The column used was Inertsil ODS C18 column, 150mm x 4.6 mm, 5m in isocratic mode, with mobile phase containing phosphate buffer and acetonitrile (50:50 v/v) adjusted to pH 3 with dilute ortho phosphoric acid solution. The flow rate was 1.0 ml/ min and effluents were monitored at 221 nm by PDA detector. The retention times of Tamsulosin and Tolterodine were found to be 2.537 min and 4.660 min, respectively. The linearity for Tamsulosin and Tolterodine were in the range of 1-6 μg/ml and 10-60 μg/ml respectively. The recoveries of Tamsulosin and Tolterodine were found to be 98.5 to 100.25% and 99.95 to 100% Tamsulosin hydrochloride and Tolterodine tartrate respectively. The proposed method was validated and successfully applied to the estimation of Tamsulosin hydrochloride and Tolterodine tartrate in combined capsule dosage forms.

Keywords: Tamsulosin, Tolterodine, HPLC, RSD, dosage.