Stress Degradation Studies on Dutasteride and Development of a Stability-Indicating HPLC Assay Method for Bulk Drug and Pharmaceutical Dosage Form
2008
Subba Rao, D. V. | Radhakrishnanand, P
A simple stability-indicating LC method has been developed for the quantitative determination of dutasteride in bulk drug samples and in pharmaceutical dosage forms in the presence of degradation products. The retention time of dutasteride is about 7 min. The drug was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. Degradation was found to occur under hydrolysis and to a lesser extent under oxidation conditions but the compound was stable to photolytic and thermal stress. The assay of stress samples was calculated against a reference standard and the mass balance was found close to 99.3%. The developed method was validated with respect to linearity, accuracy, precision and ruggedness.
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