DEVELOPMENT AND METHOD VALIDATION OF STABILITY INDICATING ASSAY METHOD OF DUTASTERIDE BY USING UV-VIS SPECTROSCOPY

The objective of the present study was to develop and validate stability indicating method to generate reliable, precise, cost effective UV-VIS spectroscopy method and accurate data for dutasteride regardless of whether it is for acceptance, release, stability or pharmacokinetic study. The solvent used was methanol and the absorption maximum λ max of the drug was found to be at 241nm. A linear response was observed in the range of 1-100µg/ml. Linear regression of absorbance on concentration gave the equation y = 0.0194x + 0.0099 with a regression co-efficient (R2) of 0.997. The method was then validated for different parameters as per the ICH guidelines. Dutasteride was subjected to stress degradation under different conditions as recommended by ICH guidelines. The degradation studies were carried out by using the developed method. The method is useful for the determination of dutasteride in bulk and pharmaceutical formulations