HPLC法同时测定痔特佳胶囊中7个成分的含量

Simultaneous determination of seven active components in Zhitejia capsules by HPLC

目的:建立HPLC法同时测定痔特佳胶囊中没食子酸、柚皮苷、槐角苷、新橙皮苷、黄芩苷、黄芩素和汉黄芩素含量。方法:采用Hydrosphere C_(18)色谱柱(250 mm×4.6 mm,5μm),以乙腈-0.05%磷酸水溶液为流动相,梯度洗脱,流速为1.0 m L·min^(-1),检测波长为280 nm,柱温为30℃。结果:没食子酸、柚皮苷、槐角苷、新橙皮苷、黄芩苷、黄芩素、汉黄芩素7个成分的线性范围分别为0.013 6~0.272 0μg(r=0.999 9)、0.025 6~0.512 0μg(r=0.999 9)、0.073 3~1.466 0μg(r=0.999 9)、0.024 8~0.496 0μg(r=0.999 9)、0.158 6~3.172 0μg(r=0.999 9)、0.019 7~0.394 0μg(r=0.999 9)、0.004 9~0.098 0μg(r=0.999 9);平均加样回收率(n=6)分别为99.3%(RSD=1.1%)、100.0%(RSD=1.5%)、98.6%(RSD=0.8%)、98.8%(RSD=1.0%)、102.0%(RSD=0.9%)、100.7%(RSD=1.4%)、98.8%(RSD=1.4%)。经HPLC法测定,3批样品中7个成分的含量分别为没食子酸2.63~3.09 mg·g^(-1)、柚皮苷6.72~7.15 mg·g^(-1)、槐角苷19.9~22.4 mg·g^(-1)、新橙皮苷5.78~6.16 mg·g^(-1)、黄芩苷45.2~49.8 mg·g^(-1)、黄芩素5.78~6.10 mg·g^(-1)、汉黄芩素1.22~1.31 mg·g^(-1)。结论:经方法学验证,本方法可用于痔特佳胶囊中没食子酸、柚皮苷、槐角苷、新橙皮苷、黄芩苷、黄芩素和汉黄芩素7个成分的含量测定。

Objective：To develop an HPLC method for simultaneous determination of gallic acid,naringin,sophoricoside,neohesperidin,baicalin,baicalein and wogonin in Zhitejia capsules.Methods：Chromatographic separation was carried out at 30 ℃ on a Hydrosphere C18 column（250 mm×4.6 mm,5 μm）,and the mobile phase consisted of acetonitrile and 0.05% phosphoric acid water in gradient elution.The flow rate was 1.0 m L·min^-1 and the detection wavelength was set at 280 nm.Results：The linear ranges of gallic acid,naringin,sophoricoside,neohesperidin,baicalin,baicalein,and wogonin were 0.013 6-0.272 0 μg（r=0.999 9）,0.025 6-0.512 0 μg（r=0.999 9）,0.073 3^（-1）.466 0 μg（r=0.999 9）,0.024 8-0.496 0 μg（r=0.999 9）,0.158 6-3.172 0 μg（r=0.999 9）,0.019 7-0.394 0 μg（r=0.999 9）,and 0.004 9-0.098 0 μg（r=0.999 9）,respectively.The average recoveries（n=6） of seven components were 99.3%（RSD=1.1%）,100.0%（RSD=1.5%）,98.6%（RSD=0.8%）,98.8%（RSD=1.0%）,102.0%（RSD=0.9%）,100.7%（RSD=1.4%）,and 98.8%（RSD=1.4%）.The contents of seven compounds in 3 batches of samples were 2.63-3.09 mg·g^-1 for gallic acid,6.72-7.15 mg·g^-1 for naringin,19.9-22.4 mg·g^-1 for sophoricoside,5.78-6.16 mg·g^-1 for neohesperidin,45.2-49.8 mg·g^-1 for baicalin,5.78-6.10 mg·g^-1 for baicalein and 1.22^（-1）.31 mg·g^-1 for wogonin.Conclusion：This method is demonstrated by methodological validation that it can be applied for simultaneous determination of seven active components（gallic acid,naringin,sophoricoside,neohesperidin,baicalin,baicalein,and wogonin） in Zhitejia capsules.