Abstract

IMPURITY METHOD DEVELOPMENT AND VALIDATION OF TAMSULOSIN HYDROCHLORIDE BY USING RP-HPLC

M. Santhi Priya*, K.Shanta kumari, M. Bhanu Prasad, G.Priyanka, T.Sirisha

Abstract

A simple, precise, rapid, specific and accurate reverse phase high performance liquid chromatographic method was developed for the estimation of Tamsulosin HCl and its related substances (impurity H and impurity I) in Tamsulosin HCl sustained release pellets. Chromatographic separation was performed on kromasil C-18 (250mmx4.6mm, 5μm) column, with mobile phase comprising of a mixture of buffer and acetonitrile (pH2.0, adjusted with conc.NaOH) in the ratio of 65:35v/v, at a flow rate of 1ml/min. The detection was carried out at 225 nm. The retention times of tamsulosin, impurity H and impurity I, were found to be 7.269, 24.902, and 48.239min respectively with a run time of 60min. As per ICH guidelines the method was validated for linearity, accuracy, precision, specificity, limit of detection and limit of quantitation, robustness and ruggedness. Linearity of tamsulosin HCl, impurity H and impurity I were found in the range of 0.0192-0.0512, 0.02- 0.12 & 0.0192-0.0512μg/mL and correlation coefficient were 0.9998, 0.9993, and 0.9995 respectively. The results clearly demonstrated that the developed method was simple, precise, rapid, selective, accurate and reproducible for the estimation of impurity H and impurity I in tamsulosin HCl.

Keywords: RP?HPLC. Tamsulosin HCl, Impurities, Validation.