HPLC法测定苦参碱葡萄糖注射液中的苦参碱

Determination of Matrine and Impurities in Matrine Glucose Injection by HPLC

目的建立苦参碱葡萄糖注射液中苦参碱及杂质的测定方法。方法采用高效液相色谱法,色谱柱Lichrospher5-NH2柱(200mm×46mm,5μm);流动相乙腈磷酸无水乙醇(55∶25∶20);流量10ml·min1;检测波长220nm;苦参碱含量测定采用外标法,杂质检查采用面积归一化法。结果苦参碱峰与杂质峰可完全分离,苦参碱浓度在20～120μg·ml1范围内线性关系良好,含量测定平均回收率为996%,RSD为055%。结论该法专属性强,操作方便,结果准确,重复性好。

Objective To establish a HPLC method for the determination of matrine and impurities in martine glucose injection.Methods Reversed phase chromatographic separation was carried out on a Lichrospher 5-NH 2 column(200 mm×4.6 mm).The mobile phase was consisted by acetonitrile-H 3PO 4-CH 3CH 2OH(55∶25∶20),and detected at 220 nm. The quantitative determination of matrine was performed with external standard method and the impurity limitation of matrine was performed with area normalization method.Resultes Complete separation was achieved among matrine and impurities under optimun condition.The standard curve was linear over the concentration range of 20～120 μg·ml -1 for matrine. The average recovery of matrine was 99.6% with RSD 0.55%.Conclustion The proposed method is accurate, simple and reproducible, and highly selective.