Abstract

DEVELOPMENT AND VALIDATIONOF OF STABILITY INDICATING HPLC METHOD FOR DETERMINATION OF TOLTERODINE TARTRATE.

Uday V. Harne, Lahu Birajdar and Mrinalini C. Damle*

Abstract

A simple and rapid stability indicating HPLC method for tolterodine tartrate was developed and validated. The stationary phase used was Thermo C18 (250 x 4.6 mm) 5 μ with a mobile phase consisting of mixture of acetonitrile and water pH 3.0 in the ratio of 70:30 v/v at a flow rate of 1.0 ml/min. Detection was carried out at 220nm. The retention time observed was 7.1 ±0.1 min. The column was maintained at ambient temperature and 20μl of solutions were injected. The eluted compound was detected by using PDA detector. The linear regression analysis data for calibration plot show good relationship with coefficient of regression value, r2=0.99 in the concentration range 5-25 μg/ml. The stress degradation studies were performed as per ICH guidelines. Tolterodine tartrate degraded with acid/base hydrolysis, thermal, oxidation and photolytic stress. The method was validated as per ICH Q2A(R1) guideline with respect to linearity, accuracy, precision, specificity and robustness. This method can be used for monitoring the stability of tolterodine tartrate. There are very few stability indicating method is present for determination of tolterodine tartrate.

Keywords: Tolterodine tartrate, stability indicating, HPLC, validation, ICH guideline.