Quantitation of alfuzosin hydrochloride in pharmaceutical formulations by RP-HPLC.

Abstract

An isocratic reversed phase high-performance liquid chromatographic (HPLC) method with ultraviolet detection at 245 nm has been developed for the determination of alfuzosin hydrochloride in dosage formulation. Good chromatographic separation alfuzosin was achieved by using a stainless steel analytical column Inertsil ODS-3V (5 microm, 15 cmx0.46 cm). The system was operated at ambient temperature (25+/-2 C) using a mobile phase consisting of acetonitrile:water:tetrahydrofuran:perchloricacid (250:740:10:1) at a flow rate of 1 ml/min. The calibration curve for alfuzosin hydrochloride was linear over the tested concentration range of 50%, 75%, 100%, 125% and 150% with reference to the label claim and a correlation coefficient of 0.999. The intra- and inter-run precision and accuracy results were 98.07 to 100.34 with the %RSD of 0.71% and tailings factor 1.07. The proposed method was validated for its selectivity, linearity, accuracy, and precision. The method was found to be suitable for the quality control of alfuzosin hydrochloride in bulk drug as well as in formulation.