液相色谱-串联四极杆质谱联用法测定中药降糖制剂中非法掺入苯乙双胍和格列齐特的研究

Detection of Phenformin and Gliclazide Illegally Mixed into Traditional Chinese Medicinal Antidiabetic Preparations by LC-QMS

目的:建立检测中药降糖制剂中非法掺入的苯乙双胍和格列齐特专属性方法。方法:采用液相色谱-串联四极杆质谱联用法。通过相对分子质量、二级质谱碎片信息、液相色谱保留时间3方面信息,对中药降糖制剂的提取液进行液相色谱-串联四极杆质谱分析。通过与对照品的色谱及质谱行为相比较,对中药降糖制剂中非法掺入的合成降糖药进行定性鉴别。结果:在4种受试中药降糖制剂中,1种被检测到同时掺有苯乙双胍和格列齐特,1种被检测到掺有苯乙双胍。结论:该方法选择性强,灵敏度高,可作为分析中药降糖制剂中非法掺人苯乙双胍和格列齐特的有效检测方法。

objective：To develop a specific method for the identification of phenformin and gliclazide illegally added into traditional Chinese medicine antidiabetic preparations and test some formulations. Methods：The liquid chromatography- quadrupole mass spectrometry method was used. After separated by HPLC, the organic extraction of the traditional Chinese medicine antidiabetic preparations was analyzed. The compounds illegally added into the traditional Chinese medicine antidiabetic preparations were identified according to the spectrum,chromatographic behavior and mass spectral data by comparison with those of reference substances. Results：Phenformin and gliclazide were found in one formulations and Phenformin was found in one formulation. Conclusion：The method is selective and sensitive and can be used to detect the illegal traditional Chinese medicine antidiabetic preparations.