Abstract

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

K. H. Manjunath, Karavadi Thejomoorthy

ABSTRACT

The Purpose of this work to develop an accurate, simple, sensitive and precise RP-HPLC method was developed for the determination of dutasteride and tamsulosin hydrochloride in tablet dosage form. The RP-HPLC separation was achieved on BDS Hypersil C18 column (250 mm, id 4.6 mm, 5 μm) using mobile phase CH3COONH4: Methanol (550:450)v/v) at a flow rate of 0.8 ml/min at an 30 0C temperature. Quantification was achieved with photodiode array detection at 254 nm over the concentration range 80μg/ml. The proposed method was validated for its linearity. Statistically, accuracy, precision and robustness. This method can be employed for routine quality control analysis of Dutasteride and Tamsulosin Hydrochloride in tablet dosage form, and also applied successfully for the determination of dutasteride and tamsulosin Hydrochloride in combination of pharmaceutical dosage form.

Keywords: Tamsulosin Hcl, Dutasteride, RP-HPLC.