METHOD DEVELOPMENT AND VALIDATION OF SIMULTANEOUS ESTIMATION OF ALFUZOSIN AND DUTASTERIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RPHPLC

Abstract

A new simple, precise, accurate and selective RP- HPLC method has been developed and validated for estimation of alfuzosin and dutasteride in pharmaceutical formulation. The detection was carried out at 216nm for both drugs. The retention time for alfu and duta were found to be 2.939min. and 7.37min. respectively. The method was validated for precision, recovery, robustness, specificity, and detection and quantification limits, in accordance with International Conference on Harmonization guidelines. Linearity was observed in the concentration range from 25% to 150% of nominal concentration of alfuzosin and dutasteride. Correlation coefficient was 0.999 for both the drugs . The % recovery was found to be within the limits of the acceptance criteria with average recovery of 99.19 % for alfuzosin and 99.29 % for dutasteride . The % RSD below 2.0 shows the high precision of proposed method.