HPLC法同时测定健儿消食口服液中

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 mL·min^-1,检测波长242 nm,柱温30℃,进样量10 μL。结果:毛蕊异黄酮苷、橙皮苷和黄芩苷的线性范围分别为0.0029~0.1160、0.0692~2.760、0.475~19.000 μg;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0.0079~0.0248 mg·mL^-1,橙皮苷的含量范围为0.217~0.376 mg·mL^-1,黄芩苷的含量范围为1.310~2.587 mg·mL^-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 calycosin 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 calycosin glucoside 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 0.007 9-0.024 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.