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目的:建立HPLC法同时测定妇科千金片中阿魏酸、绿原酸、盐酸小檗碱、穿心莲内酯、脱水穿心莲内酯及党参炔苷等6种活性成分,为妇科千金片质量提供保障。方法:采用Waters XBridge TM C_(18)柱(250 mm×4.6 mm,5μm)色谱柱;流动相为0.1%磷酸水溶液-乙腈,梯度洗脱,流速1.0 ml·min~(-1);紫外检测波长为326,316,225,254,268 nm;柱温:35℃;进样量为10μl。结果:阿魏酸、绿原酸、盐酸小檗碱、穿心莲内酯、脱水穿心莲内酯及党参炔苷的线性范围分别为0.709~28.360μg·ml~(-1),0.459~18.350μg·ml~(-1),0.510~20.380μg·ml~(-1),1.259~50.360μg·ml~(-1),0.829~33.140μg·ml~(-1),1.709~68.340μg·ml~(-1);平均加样回收率分别为99.5%,99.85%,98.8%,99.4%,98.5%,98.9%(n=6),RSD分别为0.4%,0.1%、0.7%、0.5%、0.9%、0.4%(n=6)。结论:该方法平均回收率高、简便可行、灵敏度高、重复性好,可用于控制妇科千金片中阿魏酸、绿原酸、盐酸小檗碱、穿心莲内酯、脱水穿心莲内酯及党参炔苷的质量控制。
OBJECTIVE: To establish a HPLC method for the simultaneous determination of six active ingredients of ferulic acid, chlorogenic acid, berberine hydrochloride, andrographolide, dehydroandrographolide, and ginsenoside in Gynecology Qianjin tablets, which can provide the guarantee for the quality of gynecological Qianjin tablets. METHODS: Waters XBridge C_ (18) column (250 mm × 4.6 mm, 5 μm) was used as the mobile phase. The mobile phase consisted of 0.1% phosphoric acid solution - acetonitrile and eluted with a gradient of 1.0 ml · min -1. Wavelength was 326, 316, 225, 254, 268 nm; column temperature: 35 ℃; injection volume was 10μl. Results: The linear ranges of ferulic acid, chlorogenic acid, berberine hydrochloride, andrographolide, dehydroandrographolide and dichoganenide were 0.709 ~ 28.360μg · ml ~ (-1), 0.459 ~ 18.350μg · ml 0.51 ~ 20.380μg · ml -1, 1.259 ~ 50.360μg · ml -1, 0.829 ~ 33.140μg · ml -1, 1.709 ~ 68.340μg · ml ~ (-1) -1). The average recoveries were 99.5%, 99.85%, 98.8%, 99.4%, 98.5% and 98.9%, respectively, with RSDs of 0.4%, 0.1%, 0.7%, 0.5% and 0.9% %, 0.4% (n = 6). Conclusion: The method has high average recovery rate, simple and feasible, high sensitivity and good repeatability. It can be used to control ferulic acid, chlorogenic acid, berberine hydrochloride, andrographolide, dehydroandrographolide, Glycoside quality control.