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

    February 2006 in “ Analytical Biochemistry
    Serap Saglik, Sevgi Tatar Ulu
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    TLDR New method accurately measures 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.
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