Validated HPTLC method for simultaneous analysis of alfuzosin hydrochloride and dutasteride in a pharmaceutical dosage form

Abstract

A sensitive, simple, selective, precise, and accurate HPTLC method for analysis of alfuzosin hydrochloride (ALF) and dutasteride (DUTA) both as the bulk drugs and in a tablet formulation has been developed and validated. TLC was performed on silica gel 60 F254 with toluene-methanol-dichloromethane-triethylamime 6:1:1:0.6 (ν/ν) as mobile phase. Densitometric evaluation of the separated zones was performed at 247 nm. Compact spots were obtained for ALF (RF 0.46 ± 0.03) and DUTA (RF 0.65 ± 0.03). Linear regression analysis data for the calibration plots revealed good linearity over the concentration ranges 300–600 ng per band for ALF and 500–1000 ng per band for DUTA. The method was validated for linearity, accuracy, precision, robustness, and recovery in accordance with ICH guidelines. There was no chromatographic interference from the tablet excipients. Statistical analysis showed the method enables repeatable and selective simultaneous analysis of these drugs in the tablet formulation and routine quality control of the bulk drug raw materials.