Articles Accepted

DEVELOPMENT AND METHOD VALIDATION OF STABILITY INDICATING ASSAY METHOD OF DUTASTERIDE BY USING UV-VIS SPECTROSCOPY
by Dr. SAMPADA D DALVI, 12 Sep 2018

The objective of present study is to develop and validate stability indicating method to generate reliable, precise, cost effective U.V.VIS- spectroscopy method and accurate data regardless for Dutasteride of whether it is for acceptance, release, stability or pharmacokinetic study. The solvent used was methanol and the absorption λmax 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 recommended by ICH guidelines. The degradation studies were carried out by using the developed method. Thus the method is useful for the determination of Dutasteride in bulk and pharmaceutical formulations.

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