HPLC法同时测定痔特佳胶囊中7个成分的含量

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 C₁₈色谱柱（250 mm×4.6 mm，5 μm），以乙腈-0.05%磷酸水溶液为流动相，梯度洗脱，流速为1.0 mL·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 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）、0.004 9~0.098 0 μg（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 mL·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.

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