A STABILITY-INDICATING HPLC METHOD TO DETERMINE FINASTERIDE IN A TABLET FORMULATION

Abstract

ABSTRACT A simple high performance liquid chromatographic method was developed for simultaneous determination of finasteride and its degradation products. HPLC analysis was carried out using a C18 column and methanol:water (70 : 30) as the mobile phase. Detection was carried out at 210 nm using a flow rate of 1.0 mL per min. Finasteride was eluted at 6 min. Standard deviation values were below 2%. The method was validated as stability-indicating by forced decomposition of finasteride using acid, base, hydrogen peroxide, heat, and light. Chromatograms showed good resolution, sensitivity, and no interference of degradation products. The response was linear over the concentration range of 50 to 800 µg/mL, with correlation coefficients of variation greater than 0.9995. Recovery studies gave results between 100 to 103%.