Discussion on the inspection method of methanol content in Huoxiang Zhengqi Tincture
Objective:Taking Huoxiang Zhengqi Tincture as a research object,this paper discusses the rationality of the method and limit requirements for the determination of methanol content in alcohol or tincture containing 40%～50%ethanol.Methods:The headspace gas chromatography was used to optimize the detection of methanol content in Huoxiang Zhengqi Tincture.The methanol content was determined under the column flow rate of 4.0 mL·min-1 and the split ratio of 40∶1,and the methanol content limit was analyzed and discussed.Results:The linear relationship of methanol was good within0.0500～5.000μL·mL-1,and the relative standard deviation of precision,repeatability and stability were below 2%,and the average recovery rate was 97.7%.The content of methanol in 20 batches of samples from 9 manufacturers ranged from 0.002%to 0.026%(v/v).Conclusion:The established method was sensitive,accurate,simple and fast.The limit of methanol content in Huoxiang Zhengqi Tincture was suggested to be revised to 0.01%(v/v),which is more reasonable.It provides a reference for ensuring the reproducibility of the determination of the methanol content in alcohol preparations such as alcohol or tincture,so as to ensure the safety and effectiveness of drugs.
Huoxiang Zhengqi Tincturemethanol contentlimitheadspace gas chromatography
NETL
NSTL
万方数据
维普
