检测中药降压制剂中非法掺入的氢氯噻嗪的方法

The method for determining hydrochlorothiazide illegally added into traditional Chinese medicine antihypertensive preparations

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 develop a specific method for the qualitative and quantitive detection of hydrochlorothiazide illegally added into traditional Chinese medicine antihypertensive preparations and test 6 formulations. Methods The liquid chromatography-ion trap mass spectrometry method was used for qualitative determination and high performance liquid chromatography was used for quantitive determination. The organic extract of the traditional Chinese medicine antihypertensive preparations was analyzed on a C18column with a mobile phase of methanol-acetonitrile-water （ V ： V ： V = 10 ： 25 ： 65）. Results Hydrochlorothiazide was found in 3 formulations, the contents were 0. 141%, 0. 149 % and 2. 625 % respectively. Conclusions The method is specific and sensitive and can be used to detect the illegal traditional Chinese medicine antihypertensive preparations.