Abstrakt

RP-HPLC assay method for simultaneous estimation of tamsulosin hydrochloride and finasteride in pharmaceutical dosage form

Pritam S.Jain, Abdul R.Bakhshi, Sanjay B.Bari, Sanjay J.Surana, Amar J.Chaudhari

A simple, specific, accurate and precise Reverse Phase High Performance Liquid Chromatographic method was developed for simultaneous estimation of tamsulosine hydrochloride and finasteride in tablet dosage form on RP C18BDScolumn (250mm×4.6 mm, 5µm) with a mobile phase consisting of methanol: water (70:30, v/v) (pH 3.7) adjusted with ortho phosphoric acid, with a flowrate of 1ml/min, UV detection at 260 nmwas used. The retention time for tamsulosine hydrochloride and finasteride were found to be as 2.68 and 7.33 min, respectively. Proposed method was validated for precision, accuracy, linearity, range, robustness, ruggedness and force degradation study. The calibration curve of tamsulosine hydrochloride and finasteride were linear over the range of 4-24 µg/ml (r2=0.9997) and 20-120 (r2=0.9998) µg/ml respectively. The method was found to be sensitive with limit of detection of tamsulosine hydrochloride and finasteride was determined 0.28 and 0.85 and limit of quantitation of was determined 1.03 and 3.22µg/ml, respectively. The method has been successively applied for the determination of tamsulosine hydrochloride and finasteride in tablets. There was no interference fromthe excipients commonly present in the tablets.Accuracy of the method was studied by the recovery studies at three different levels 80%, 100%and 120%. The%recoverywas found to be within the limits of the acceptance criteria with average recovery of 99.9%–100.54% for tamsulosine hydrochloride and 99.83%–100.92% for finasteride. The % RSD below 2.0 shows the high precision of proposed method.