METHOD DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRIC ESTIMATION OF FINASTERIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Abstract

A simple, rapid, and cost-effective UV–Visible spectrophotometric method was developed and validated for the quantitative estimation of finasteride in bulk drug and pharmaceutical dosage forms. Finasteride, a selective inhibitor of type II 5?-reductase, is widely used in the management of benign prostatic hyperplasia and androgenic alopecia. The proposed method was based on measurement of absorbance at a wavelength of approximately 210 nm using methanol as solvent. The method exhibited good linearity over the concentration range of 2–10 µg/mL with a high correlation coefficient (r² ? 0.999), indicating adherence to Beer–Lambert’s law.Validation of the method was carried out in accordance with ICH guidelines, including parameters such as accuracy, precision, linearity, ruggedness, limit of detection (LOD), and limit of quantification (LOQ). The accuracy studies showed satisfactory recovery within 98–102%, while precision studies demonstrated low %RSD values (<2%), confirming reproducibility. The method also showed adequate sensitivity with acceptable LOD and LOQ values.Overall, the developed UV spectrophotometric method is reliable, economical, and suitable for routine quality control analysis of finasteride in pharmaceutical formulations.