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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);0.08~0.80μg(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 establish an HPLC-DAD method for the determination of hydrochlorothiazide and amlodipine besylate added to Jiuweisujisuangan Capsule to combat the illegal addition of chemical drugs in health foods. METHODS: The mobile phase B was eluted with a gradient of Phenomenex C18 (250 mm × 4.6 mm, 5 μm) using acetonitrile as mobile phase A and 0.02 mol·L-1 potassium dihydrogen phosphate solution (pH 3.5) 1.0 ml · min-1, the column temperature was 26 ℃, the detection wavelength was 220 nm, and the injection volume was 10μl. Results: The linear ranges of hydrochlorothiazide and amlodipine besylate were 0.24 ~ 2.43μg (r = 0.999 6) and 0.08 ~ 0.80μg (r = 0.999 7) respectively. The average recoveries were 100.2% (RSD = 1.4%, n = 6), 99.9% (RSD = 1.6%, n = 6). Conclusion: The method has high selectivity, high sensitivity, simple treatment and rapid determination. It can be used in the testing of illegally added hydrochlorothiazide and amlodipine besylate.