UV Spectrophotometric Stability Indicating Method Development and Validation for the Determination of Finasteride in Bulk and Dosage Form

July 2019 in “ Journal of Drug Delivery and Therapeutics ”

Shraddha T. Nemane, Sachin B. Gholve, Omprakash G. Bhusnure, Trupti M. Rajmanya, Shivani V. Kaulkhere, Sagar S. Waghmare

finasteride UV spectrophotometric method methanol λmax linearity correlation coefficient mean recovery limits of quantification limits of detection ICH guidelines Propecia

TLDR The method accurately measures finasteride in bulk and dosage forms.

The study developed and validated a simple, specific, and economical UV spectrophotometric method to determine finasteride content in bulk and pharmaceutical dosage forms. Using methanol as a diluent, the method measured finasteride at a λmax of 255 nm, showing linearity in the range of 2-12 μg/mL with a high correlation coefficient (R²=0.999) and excellent mean recovery (98-99%). The limits of quantification (LOQ) and detection (LOD) were 1.178 μg/mL and 5.40 μg/mL, respectively. The method was validated for linearity, precision, repeatability, and reproducibility according to ICH guidelines, proving suitable for routine analysis of finasteride in both bulk and commercial formulations.

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