SIMULTANEOUS DETERMINATION OF FINASTERIDE AND TAMSULOSIN IN COMBINED DOSAGE FORM BY USING RP-HPLC METHOD

Abstract

A simple, accurate, economical, and reproducible reversed-phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous determination of finasteride and tamsulosin in bulk and pharmaceutical formulations. The separation was achieved on a phenomenex C18 column (150 × 4.6 mm i.d, particle size of 5 µ) using a mixture of 0.1% triethylamine (pH adjusted to 7.01 ± 0.05 with 0.1% ortho phosphoric acid) and methanol in the ratio of 30:70% v/v as the mobile phase in an isocratic elution mode, at a flow rate of 0.7 mL/min. The detection was monitored at 220 nm. The retention times of finasteride and tamsulosin were found to be 5.8 ± 0.12 min and 2.9 ± 0.14 min, respectively. Excellent linearity range was found between 10–100 µg/mL for finasteride and 2–8 µg/mL for tamsulosin. The method was validated with respect to linearity, precision, accuracy, specificity, robustness, and ruggedness. The method was successfully applied for the simultaneous determination of finasteride and tamsulosin from the combined dosage form.