Determination of Finasteride in Tablets by High Performance Liquid Chromatography

A rapid, highly sensitive high performance liq. chromatog. method was developed for the detn. of finasteride (FNS) in bulk drug and in tablets. FNS was eluted from a ODS C18 reversed phase column at lab. temp. (30°) with a mobile phase consisting of methanol and water (80 + 20) at a flow rate of 1 mL min-1 with UV detection at 225 nm. The retention time was ∼6.1 min and each anal. took not more than 10 min. Quantitation was achieved by measurement of peak area without using any internal std. Calibration graph was linear from 2.0-30 μg mL-1 with limits of detection (LOD) and quantification (LOQ) being 0.2 and 0.6 μg mL-1, resp. The method was validated according to the current ICH guidelines. Within-day co efficients of variation (CV) ranged from 0.31-0.69% and between-day CV were in the range 1.2-3.2%. Recovery of ENS from the pharmaceutical dosage forms ranged from 97.89-102.9 with CV of 1.41-4.13%. The developed method was compared with the official method for ENS detn. in its tablet forms. [on SciFinder(R)