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目的建立定性及定量检测中药制剂中非法掺入的氢氯噻嗪的专属性方法,并对6批市售药品进行检测。方法采用液相色谱-离子阱质谱法进行定性鉴别,采用高效液相色谱法进行含量测定。选用C18色谱柱,以甲醇-乙腈-水(体积比为10∶25∶65)为流动相,对中药制剂的提取液进行分析。结果在6批受试制剂中,3批被检测出非法掺有合成药氢氯噻嗪,其含量质量分数分别为0.141%、0.149%和2.625%。结论该法可以作为分析检测非法降压制剂的有效方法。
Objective To establish a method for the qualitative and quantitative detection of hydrochlorothiazide illegally mixed in traditional Chinese medicine preparations and to test six batches of commercial drugs. Methods The liquid chromatography-ion trap mass spectrometry was used for qualitative identification, and the content was determined by high performance liquid chromatography. The C18 column was used to analyze the extract of Chinese medicine preparation with methanol-acetonitrile-water (volume ratio 10:25:65) as the mobile phase. Results Among the six batches of test preparations, three batches of drugs that were illegally mixed with synthetic hydrochlorothiazide were detected, and their contents were 0.141%, 0.149% and 2.625% respectively. Conclusion This method can be used as an effective method for the analysis of illegal hypotensive agents.