Stability Indicating Method Development and Validation of Finasteride by High-Performance Thin-Layer Chromatography Studies

摘要

The present research work determines the stability of finasteride by forced degradation studies. Finasteride was treated with hydrolytic stressors such as acid, alkali and neutral stress, further finasteride was also treated with oxidative, photolytic and thermal stress conditions. Method development, validation and separation of the degradation products for the drug were carried out by using high-performance thin-layer chromatographic system (HPTLC). The drug was found to degrade under basic and oxidative stress conditions. The mobile phase composition for HPTLC analysis consisted of chloroform-methanol (8:2 % v/v). The UV spectrophotometry spectra of finasteride showed λ_(max) at 210 nm; hence this wavelength was chosen for densitometric analysis. The R_F value for finasteride was found to be 0.57 with a compact spot. The method was validated as per ICH guidelines Q2(R 1) and good linear relationship was observed in the concentration range of 200-1400 ng band~(-1). Percent recovery for the drug was within limit and was found to be in the range of 98.52-99.66 %. For precision studies the % relative standard deviation (% RSD) was < 1.5 %. The developed HPTLC method has been successfully applied for the analysis of finasteride in tablet dosage form.