HPLC法同时测定健儿消食口服液中毛蕊异黄酮苷、橙皮苷和黄芩苷的含量

Simultaneous determination of the content of calycosin glucoside,hesperidin and baicalin in Jian'er Xiaoshi oral liquid using HPLC

目的：建立一种可以同时测定健儿消食口服液中毛蕊异黄酮苷、橙皮苷和黄芩苷含量的高效液相色谱法。方法：样品用甲醇超声提取;采用Agilent ZORBAXSB-C18（150 mm×4.6 mm,3.5μm）色谱柱,以乙腈（A）-1%乙酸溶液为流动相,梯度洗脱（0~10 min,5%A→10%A;10~19 min,10%A→11%A;19~27 min,11%A;27~40 min,11%A→14%A;40~45 min,14%A→15%A;45~60 min,15%A;60~70 min,15%A→17%A;70~80 min,17%A→20%A）,流速1.0 m L·min-1,检测波长242nm,柱温30℃,进样量10μL。结果：毛蕊异黄酮苷、橙皮苷和黄芩苷的线性范围分别为0.002 9~0.116 0、0.069 2~2.760、0.475~19.000μg;平均加样回收率（n=6）分别为95.3%、99.0%、97.0%,RSD分别为1.5%、1.6%、1.1%。20批样品中毛蕊异黄酮苷、橙皮苷和黄芩苷含量测定结果为：毛蕊异黄酮苷的含量范围为0.007 9~0.024 8 mg·m L-1,橙皮苷的含量范围为0.217~0.376 mg·m L-1,黄芩苷的含量范围为1.310~2.587 mg·m L-1。结论：经方法学验证,本法可测定制剂中毛蕊异黄酮苷、橙皮苷和黄苓苷的含量。

Objective：To establish an HPLC method to measure the content of ealycosin glucoside, hesperidin and baicalin in Jian＇er Xiaoshi oral liquid at the same time. Methods：Samples were extracted by methanol ultrasonic, then analyzed on an Agilent ZORBAXSB-C18 column （150 mm × 4. 6 mm, 3.5 μm） with the mobile phase acetonitrile-1% acetic acid by gradient elution（0-10 min, 5%A→10%A; 10-19 min, 10%A→11%A; 19-27 min, 11%A; 27-40 min, 11%A→14%A; 40-45 min, 14%A→15%A; 45-60 min, 15%A; 60-70 min, 15%A→ 17% A; 70-80 min, 17% A→20% A） at a flow rate of 1.0 mL · min-1 The detection wavelength was set at 242 nm,the column temperature was 30 ℃, and the sample volume was 10 μL. Results：The linear range of calyeosin glueoside was 0. 002 9-0. 116 0 μg; and the linear range of hesperidin was 0. 069 2-2. 760 μg; also the linear range of baicalin was 0. 475-19. 000 μg. Their average recoveries（ n = 6） were 95.3% , 99.0% , and 97.0% , respectively, and the RSD was 1.5% , 1.6% , and 1.1% respectively. The content of calycosinglucoside in the 20 batches of samples ranged from 0. 0079-0. 024 8 · mL-1, the content range of hesperidin was 0. 217-0. 376 mg · mL-1, and the content range of baicalin was 1.310-2. 587 mg· mL-1. The contents of three active ingredients in 20 batches of samples were relatively stable. Conclusion： Methodological research confirmed that the established method can be adopted to measure the contents of three main active ingredients of Jian＇er Xiaoshi oral liquid at the same time.