HPLC-DAD法同时测定乙肝扶正胶囊中6种有效成分的含量

Simultaneous Determination of 6 Active Ingredients in Yigan Fuzheng Capsules by HPLC- DAD

目的 建立同时测定乙肝扶正胶囊中6种有效成分含量的方法.方法 采用二极管阵列检测器（DAD）波长切换高效液相色谱法.流动相为乙腈-甲醇-0.1%醋酸水溶液（梯度洗脱）,检测波长为320nm（0-40min）,切换为254nm（40-65min）检测5家厂乙肝扶正胶囊的有效成分.结果 没食子酸、虎杖苷、二苯乙烯苷、白藜芦醇、肉桂醛、丹参硐ⅡA 6个有效成分的色谱峰能有效分离,其质量浓度分别在0.244-4.88、0.196-3.92、0.272-5.44、0.208-4.16、0.272-5.44、0.200-4.00mg·ml-1范围内与各自峰面积积分值呈良好的线性关系（r≥0.99）;其检出限分别为2.86-8.86ng·ml-1,定量限分别10.06-20.86ng·ml-1,均符合含量测定要求.5家厂的产品中的6种有效成分均能同时检出.结论 本方法快速、准确、重复性好,可用于乙肝扶正胶囊的质量控制.

Objective To establish a method to simultaneously determine the contents of 6 active ingredients in Yigan Fuzheng Capsules. Methods HPLC-DAD with wavelength switching system was used, as the column, acetonitrile-methanol-0. 1% acetic acid solution （gradient elution） as the mobile phase, detection wavelengths at 320nm （0-40min）, and at 254min （40-65min） to detect the activc ingredients in Yigan Fuzheng Capsules in 5 manufacturers. Results The spectra of the 6 active ingredients were effectively separated, with good linear correlation with peak areas, and the linear ranges were （0. 244-4. 88mg · ml-1 for gallic acid, 0. 196-3.92mg · ml-1 for polygon in, （0. 272-5.44mg · ml-1 for stilbene glycoside,0. 208-4. 16mg · ml-1 for resveratrol, cinnamyl aldehyde and 0. 200-4. 00mg ·ml-1 for tanshinone ⅡA （ r≥0. 99）. The detection limits were 2.86-8. 86mg·ml-1 , quantization limits were10.06-20. 86ng ·ml-1, consistent with the requirements on ingredient contents. The 6 active ingredients could be detected in products of 5 manufacturers. Conclusion The method is rapid, accurate, with good repeatability, which is suitable for quality control of Yigan Fuzheng Capsules.