Abstract

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

S.C.Rajesh*, K. Neelima, P.Solairaj

Abstract

Benign Prostatic Hyperplasia (BPH) is a common problem that affects approximately one third of men older than 50 years. A combination therapy with both alpha blockers and 5-alpha reductase inhibitors is having better patient acceptance on a long term basis. This usage results in the shrinkage of prostate by as much as 26 % and it retards BPH-related surgery by 57 %. From the literature survey, it was revealed that no suitable method has been developed for this combination. Therefore an attempt has been made to develop and validate an analytical method for the simultaneous estimation of dutasteride and tamsulosin hydrochloride in capsule dosage form by RP-HPLC technique. The process was carried out using the mobile phase containing the mixture of methanol: buffer (100 mM dipotassium hydrogen phosphate with pH 9.5) in the ratio 20:80 (%v/v) with flow rate of 1.2 mL/min in Dionex,C18 (250×4.6) mm, 5μ column with a injection volume of 20μL and detected at 295 nm. The linearity was found in the concentration range 50-150 μg/mL and 40-120 μg/mL with correlation coefficients calculated as 0.9993 and 0.9997 and the % recovery was found to be 98.53 and 99.36 for both dutasteride and tamsulosin hydrochloride. The developed method is found to be simple, economical, time saving, accurate, precise, linear, specific, rugged and robust. This method may be recommended for the routine analysis in combined dosage forms and in API.

Keywords: Dutasteride, Tamsulosin HCl, RP-HPLC, Benign Prostatic Hyperplasia.