A Simple, Stability indicating, Isocratic, reverse phase High Performance Liquid Chromatographic (RPLC) related substance method was developed for Dutasteride in API. This method separates the impurities which are co-eluting in the pharmacopeia method. Successful separation of degradation impurities and synthetic impurities was achieved by YMC Triat phenyl column. Chromatographic was carried out on YMC Triat phenyl (150 X 4.6 mm, 3.0µm) column using 0.01M Potassium Dihydrogen Phosphate, pH to 2.5 with 1mL of trimethylamine as additive and acetonitrile. The developed HPLC method was validated with respect to linearity, accuracy, precision, ruggedness, robustness and specificity.
KEYWORDS: Dutasteride, Impurities, HPLC, UV Detector and Validation.