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Abstract

METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORMS BY RP-HPLC

Jahnavi Bandla*, Gorja Ashok

ABSTRACT

A simple, rapid, accurate and precise method was developed and validated for the simultaneous estimation of Dutasteride and Tamsulosin hydrochloride in pharmaceutical dosage form. The method was based on RP-HPLC. Chromatographic separation was performed on Xterra-symmetry C18 (150mm x 4.6mm, 5μm particle size) column using a mobile phase consisting of a mixture of Phosphate buffer (pH 2.5 with dilute orthophosphoric acid): Acetonitrile (20:80%v/v) in an isocratic mode. The following system conditions were maintained throughout development and validation i.e., flow rate 0.8mL/min, column was maintained at room temperature and the detected by a UVwave length at 274nm. The Dutasteride and Tamsulosin hydrochloride were well resolved on the stationary phase and the retention times were 2.0 and 5.0minutes respectively. The method was validated; Dutasteride and Tamsulosin hydrochloride both were shown to be linear over a range of 25- 75μg/mL. The limit of quantification was 18.1μg/mL for Dutasteride and 18.7μg/mL for Tamsulosin hydrochloride and the limit of detection was 5.9μg/mL for Dutasteride and 6.2μg/mL for Tamsulosin hydrochloride. The Precision, Accuracy, Specificity, Ruggedness and Robustness were determined to validate the method.

Keywords: Dutasteride, Tamsulosin hydrochloride, RP-HPLC, Method development, Validation and C18 Column


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