高效液相色谱法测定肝酶灵注射液中苦参碱的含量

Determination of matrine in Ganmeiling injection by HPLC

目的：为控制肝酶灵注射液中苦参碱的含量，建立了高效液相色谱测定方法。方法：色谱柱为BDS-C18柱(4 mm×250 mm,5 μm)，以甲醇-水-三乙胺(50∶50∶0. 2，氨水调pH至9～10)为流动相，流速0.8 ml·min-1，紫外检测波长220 nm。 结果：苦参碱在73～440 μg·ml-1范围内，可得良好的线性关系，r=0.9993,平均 加样回收率为101.6%，RSD为2.52%。结论：本法简便、快速、准确，适用于该药品生产及临床应用中的质量监控。

：OBJECTIVE To establish an HPLC method for determining matrine in Ganmeiling injection .METHODS The experimental conditions in the method were BDS-C18 column (5 μm, 250 mm×4 mm) and MeOH-water-triethylamine (50∶50∶0.2,adjusted to pH 9～10 with ammonia solution) as the mobile phase.The elute with a flow rate of 0.8 ml·min-1 was detected 220 nm. RESULTS The calibration curve was in good linearity over the range of 73～440 μg·ml -1(r=0.9993).The average recovery was 101.6%,RSD was 2.25 (n=3). CONCLUSIONS This HPLC method is simple,rapid,accurate,and is suitable for the quality contro l.