NOVEL RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF TAMSULOSIN HCl AND DUTASTERIDE IN TABLETS BY RATIO’S METHOD

A novel simple selective, precise and accurate RP-HPLC method were developed for the simultaneous estimation by ratio's method of Tamsulosin HCl and Dutasteride in the combined formulation.The drugs were estimated for the ratio's of the peak areas for Tamsulosin HCl, Dutasteride and the internal standard.The internal standard selected was propylparaben.The drugs and internal standard were separated on Kromasil C18 (250x4.6,5µ) with a reverse phase isocratic elution.A mixed phosphate buffer 35 volumes and acetonitrile 65 volumes were used as a mobile phase.the flow rate was 1.0 mL/min.225 nm was the detection wavelength.The retention times were 2.804 min for Tamsulosin HCl, 4.371 min for internal standard(propylparaben) and 12.914 min for Dutasteride.The linearity ranges for Tamsulosin HCl and Dutasteride were 20.00 to 60.00 and 25 to 75 mcg/ml respectively with a correlation coefficient of 0.999 for both.The proposed ratio's method validated statistically concerning system suitability, specificity, linearity, precision, accuracy, range, robustness and ruggedness.The method was accurate, linear, precise, specific, selective and rapid suitable for the quantitative estimation of Tamsulosin HCl and Dutasteride by ratio's method.