对《中国药典》2015年版甲醇量检查法(第一法)的探讨

Discussion on Method A of Determination of the Content of Methanol in Chinese Pharmacopoeia 2015

目的:对《中国药典》2015年版甲醇量检查法(第一法)进行探讨。方法:用乙醇溶液代替水为溶剂配制甲醇对照品溶液,采用气相色谱法,顶空进样的方式,测定含乙醇制剂中的甲醇量。结果:改进后的方法经方法学验证,回收率为99.3%,重复性试验RSD为2.9%。结论:改进后的方法使对照品溶液和样品溶液基体相匹配,测得值更接近样品中甲醇的真实含量,建议采用改进后的方法测定含乙醇制剂中的甲醇量。

Objective ： To discuss method A for determination of content of Methanol in ChP 2015. Methods ： Ethanol was used as solvent instead of water for preparation of the methanol reference solution. The gas chromatography was used with headspaee sampling to determine the content of methanol in the preparations that contain ethanol. Results： The improved method was validated with the recovery as 99. 3% and the RSD of repeatability as 2.9%. Conclusion： The improved method makes the reference solution and test solution matrix matching, and the test results are more approach to the real content of methanol in the samples. It is suggested to use the improved method to determine the content of methanol in the preparations that contain ethanol.