Determination of Residual Organic Solvents in Finasteride Raw Materials by Headspace Capillary Gas Chromatography
January 2013
in “
Zhongguo yaofang
”
New to Finasteride? There is a guide in the encyclopedia. Read the guide → Studysummary This study established a sensitive and reproducible method for determining the levels of four organic solvents in finasteride raw materials, meeting the requirements of the Chinese Pharmacopeia.
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The study aimed to establish a method for determining residual organic solvents in finasteride raw materials, specifically methanol, acetone, chloroform, and methylbenzene, using headspace gas chromatography. The method involved separation on a Phenomenex ZB-624 capillary column with dimethyl sulfoxide as the solvent and utilized a flame ionization detector. The results showed linear ranges for the solvents with high correlation coefficients (r=0.9996 to 0.9998) and recovery rates between 94.7% and 97.5%. The detection limits ranged from 0.0216 to 10.93 μg/ml. The residual amounts in 5 batches of samples met the Chinese Pharmacopeia (2010 edition) requirements, indicating that the method was sensitive, reproducible, and suitable for its intended purpose.