Determination of Residual Solvents in the Injection Xushuantong （Freeze-dried） by Headspace Capillary Gas ChromatographyChinese Full Text
YAN Yun;ZHANG Yun-Yun;LUO Yi;Guangxi Institution for Food and Drug Control;Guangxi Institution of Chinese Medicine ＆ Pharmaceutical Science;
Abstract: Objective:To establish Headspace Capillary Gas Chromatography method for the determination of the residual solvents in the injection Xushuantong（freeze-dried）. Methods: The Chromatographic conditions adopted were DB-624 capillary column（30 m×0.25 mm×1.40 μm）, with nitrogen as carrier gas and FID as detector.The temperature program and split injection mode were used.Results: The calibration curves of Methanol, ethanol, acetone, n-heXane, ethYl acetate, n-butYl alcohol, benzene, toluene, XYlene, 1,2-2 eth Yl benzene and dieth Yl benzene showed good linear relationship. The precision was lower than 2.8%. The average recoveries was 99.5%-104.1%（RSD=1.0%-4%）. Conclusion: This method is accurate and reliable. It can be used for detection of the residual solvents in in the injection Xushuantong（freeze-dried）.
Keywords：
The injection Xushuantong（freeze-dried）; Residual solvent; Headspace Capillary Gas Chromatography;
- DOI：
10.13862/j.cnki.cn43-1446/r.2014.07.029
- Series：
- Subject：
- Classification Code：
R927.2;O657.71
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