Development and validation of RP-HPLC method for simultaneous estimation of Alfuzosin Hydrochloride and Dutasteride in pharmaceutical dosage form

By Shivprasad S. Deshmukh, Shweta S. Havele, Vaishali V. Musale, Sunil R. Dhaneshwar

ABSTRACT


A simple, rapid, specific and sensitive Reverse Phase-HPLC method has been developed and validated for the simultaneous estimation of alfuzosin hydrochloride (ALF) and dutasteride (DUTA) in Bulk powder and pharmaceutical dosage form. The RP-HPLC separation was performed on HiQ Sil C18HS column (4.6mm I.D X 250 mmL) using mobile phase       methanol: water (90:10 v/v) at a flow rate of 1 ml/min at an ambient temperature. Quantitation by HPLC was achieved with UV detection at 244 nm based on peak area with linear calibration curves at concentration ranges 1-5 µg/ml and 4-20 µg/ml for ALF and DUTA, respectively. The limit of detections (LOD) was 0.2 µg/ml and 1 µg/ml for ALF and DUTA, respectively. The method was validated for linearity, accuracy, specificity, precision, robustness and recovery as per ICH guidelines. The method was applied for analysis of pharmaceutical dosage form and no chromatographic interference from the tablet excipients was found. Statistical data reveals that the method is accurate, repeatable and selective for the simultaneous quantitation of the above drugs in pharmaceutical dosage form and for routine analysis of raw material of drugs in quality control laboratories.

Keywords: High performance liquid chromatography, Pharmaceutical analysis, Benign prostatic hyperplasia, Dutasteride, Alfuzosin.

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