Development and Validation of a New Gas Flame Ionization Detector Method for the Determination of Finasteride in Tablets

This paper describes the development and validation of a gas chromatography method for the determination of finasteride in tablets. The method involves a derivatization reaction and was found to be simple, specific, precise, accurate, and reproducible. The assay was linear over the concentration range of 10 to 50 µg ml¯¹, with a limit of detection (LOD) of 2 µg ml-¹ and a limit of quantification (LOQ) of 10 µg ml-¹. The method was successfully applied to estimate the amount of finasteride in tablets, and the results were compared statistically with those obtained by the official method using t and F tests. There was no significant difference between the two methods with respect to mean values and standard deviations at the 95% confidence level.