HPLC法测定平肺口服液中5个成分的含量

目的：建立HPLC法测定平肺口服液中芥子碱、绿原酸、五味子醇甲、贝母素甲、贝母素乙的含量。方法：采用HPLC-DAD法，以乙腈（A）-0.1%磷酸溶液（B）为流动相进行梯度洗脱，流速1.0 mL·min^-1，检测波长327 nm（0~40 min）、216 nm（40~80 min），测定芥子碱、绿原酸、五味子醇甲的含量；采用HPLC-ELSD法，以乙腈-0.1%二乙胺溶液（60：40）为流动相，流速1.0 mL·min^-1，ELSD漂移管温度85℃，载气体积流量2.0 L·min^-1，利用MCX混合型阳离子交换小柱进行固相萃取，测定贝母素甲、贝母素乙的含量。结果：芥子碱、绿原酸、五味子醇甲、贝母素甲、贝母素乙进样量分别在0.027 92~0.335 0 μg（r=0.999 9）、0.04044~0.4 853 μg（r=0.999 9）、0.012 90~0.154 8 μg（r=0.999 9）、0.3 081~3.081 0 μg（r=0.999 9）、0.317 4~3.174 0 μg（r=0.999 9）范围内线性关系良好，平均回收率分别为101.0%、103.1%、103.8%、93.8%、94.4%，RSD分别为1.2%、0.46%、0.83%、2.1%、1.8%（n=9）。结论：该方法简便、准确，专属性强，可用于该制剂的质量控制。

Objective: To establish an HPLC method for determination of sinapine,chlorogenic acid,schisandrin, peimine and peiminine in Pingfei oral liquid. Methods: Sinapine,chlorogenic acid and schisandrin were determined by HPLC-DAD method. The mobile phase was acetonitrile (A) -0.1% phosphoric acid solution (B) with gradient elution,the flow-rate was 1.0 mL·min^-1 and the detection wavelengths were 327 nm (0-40 min) and 216 nm (40-80 min). Peimine and peiminine were determined by HPLC-ELSD method. The mobile phase was acetonitrile-0.1% diethylamine solution (60:40),the flow-rate was 1.0 mL·min^-1,the temperature for the detector drift tube was 85℃, and the gas flow-rate was 2.0 L·min^-1. Mixed cation exchange (MCX) column was used for solid phase extraction (SPE). Results: The methods achieved good linearity in the ranges of 0.027 92 -0.335 0 μg (r=0.999 9) for sinapine, 0.0404 4-0.485 3 μg (r=0.999 9) for chlorogenic acid, 0.012 90-0.154 8 μg (r=0.999 9) for schisandrin, 0.3 081 -3.081 0 μg (r=0.999 9) for peimine and 0.317 4 -3.174 0 μg (r=0.999 9) for peiminine,respectively. The average recoveries (n=9) were 101.0% (RSD=1.2%), 103.1% (RSD=0.46%), 103.8% (RSD=0.83%), 93.8% (RSD=2.1%) and 94.4% (RSD1.8%), respectively. Conclusion: The method is simple, accurate,specific and can be used for quality control of the preparation.

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