LC determination of finasteride and its application to storage stability studies

The development of a simple, sensitive, rapid, and reproducible reversed-ph ase high-performance liquid chromatographic assay of finasteride (proscar) in preformulation, and its application to forced degradation studies has be en carried out. The method showed excellent linearity (r(2) greater than or equal to 0.9997) in the range 20-600] mug ml-(1) using a Shimpak C-8 colum n (5 mum, 15.0 cm x 4.6 mm) and UV-detection (210 nm) at ambient temperatur e(25 +/- 1 degreesC) with a mobile phase of acetonitrile and water (95:05,v /v) and flow rate of 0.7 ml min(-1). All peaks are eluted in (10 min and th e method has good precision. This method showed good efficiency for the ana lysis of forced degraded samples, studied at different temperatures and hum idities. The results manifest that the shelf-life of proscar is greater tha n two years at room temperature, under proper storage conditions. (C) 2001 Elsevier Science B.V. All rights reserved.