Determination of Two Related Substances in Sophobuvir Raw Materials by Gas Chromatography
Establish a gas chromatography method for simultaneous determination of two organic impurities,pentafluorophenol and the starting material 2 of sorafuvir,in the raw material of sorafuvir.A capillary column with a fixed liquid of 5%phenyl-95%methylpolysiloxane(or similar polarity)was selected as the chromatographic column.The temperature was programmed to rise,the injection port temperature was 200℃,the FID detector temperature was 300℃,the carrier gas was helium,the carrier gas flow rate was 4.0 mL/min,the split ratio was 10:1,and the injection volume was 1 μL.The equilibrium time is 30 minutes.The two organic impurities have a good linear relationship with the chromatographic peak area within their respective mass concentration ranges,and the correlation coefficients are not less than 0.999.The detection limits of both organic impurities are not greater than 2 μg/mL.The recovery rate of sample spiking is 94.00%～117.06%.This method is simple to operate,highly sensitive,and accurate in results,and can be used for the determination of organic impurities in the raw material of Sophobuvir.
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