HPLC-DAD法检查九味双降素稳安胶囊中非法添加的氢氯噻嗪、苯磺酸氨氯地平

Determination of Hydrochlorothiazide and Amlodipine Besylate Illegally Added in Jiuweishuangjiangsu-wenan Capsules by HPLC-DAD

目的：建立HPLC-DAD方法检查九味双降素稳安胶囊中非法添加的氢氯噻嗪、苯磺酸氨氯地平,以打击保健食品中非法添加化学药物现象.方法：采用Phenomenex C18（250 mm×4.6 mm,5μm）色谱柱,以乙腈为流动相A、0.02 mol·L-1磷酸二氢钾溶液（pH3.5）为流动相B进行梯度洗脱,流速为1.0 ml·min-1,柱温为26℃,检测波长为220 nm,进样量为10μl.结果：氢氯噻嗪、苯磺酸氨氯地平线性范围分别为0.24 ～2.43μg（r =0.999 6）;0.08 ～0.80 μg（r =0.999 7）,平均回收率分别为100.2％（RSD=1.4％,n=6）,99.9％（RSD=1.6％,n=6）.结论：本方法选择性强、灵敏度高、处理方法简单、测定快速,可用于九味双降素稳安胶囊中非法添加氢氯噻嗪、苯磺酸氨氯地平的检查.

Objective：To develop an HPLC-DAD method for the analysis of hydrochlorothiazide and amlodipine besylate illegally added in Jiuweishuangjiangsuwenan capsules.Methods：A Phenomenex C18 （250 mm × 4.6 mm,5 μm） column was used,the mobile phase consisted of A （acetonitrile） and B （0.02 mol · L-1 potassium dihydrogen phosphate solution,pH 3.5） with gradient elution and the flow rate was 1.0 ml · min-1.The column temperature was 26℃,the detection wavelength was 220nm and the sample size was 10 μ1.Results：Hydrochlorothiazide and amlodipine besylate showed good linearity within the range of 0.24-2.43 μg（r =0.999 6）and 0.08-0.80 μg（r =0.999 7）,respectively.The average recovery of hydrochlorothiazide and amlodipine besylate was 100.2%（RSD =1.4%,n =6） and 99.9% （RSD =1.6%,n =6）,respectively.Conclusion：The method is specific,sensitive,simple and quick,and can be used in the detection of hydrochlorothiazide and amlodipine besylate illegally added in Jiuweishuangjiangsuwenan capsules.