Abstract

Devi Thamizhanban*, Dr. Gampa Tulja Rani and Dr. Kathiresan Krishnasamy

ABSTRACT

The research work was aimed to develop a dissolution method for simultaneous estimation of Dutasteride and Tamsulosin from extended-release capsule. The formulation is having Dutasteride in immediate release and Tamsulosin in modified release form. A change over dissolution media was developed in this study. 0.1N HCl with 0.2% SLS was selected as dissolution medium to enable complete dissolution of Dutasteride for initial two hours, and continued by changing the dissolution medium to pH 7.2 phosphate buffer for 8 hours, using USP Apparatus 1, at 100RPM. Working standards were prepared by using the respective dissolution media, for specific sample. Chromatographic separation was achieved by analysing filtered sample, using Agilent's high performance liquid chromatograph and X bridge C18, 5µm, 4.6 x 150mm column, with solvent-A of 0.05M phosphate buffer (pH 6.8), and solvent-B of acetonitrile by gradient elution technique. The flow rate was maintained at 1.5 ml/min and the detection wavelength was 225nm, with sample run time of 18 minutes. In acid stage Tamsulosin was eluted at 5.7 minutes, and Dutasteride was eluted at 9.4minutes. Buffer stage was developed only for Tamsulosin and eluted at 2.3minutes. Analytical method was validated and complies to the regulatory guidelines. The effect of RPM on dissolution profile was evaluated, which does not have any significance on drug release, and F2 value of 65 & 84 with 75 RPM & 91 and 71 with 125RPM against 100RPM for Dutasteride and Tamsulosin, respectively. Hence, the developed method is suitable for estimating drug release of both components simultaneously.