HPLC法测定甲磺酸二氢麦角碱注射液的含量及有关物质

HPLC determination of dihydroergotoxine methanesulfonate and related substances in dihydroergotoxine methanesulfonate injection

目的用HPLC法测定甲磺酸二氢麦角碱注射液的含量及有关物质。方法采用Diamonsil C18(200mm×4.6mm,5μm);水-乙腈-三乙胺(62∶40∶2)为流动相;流速1.5ml/min;检测波长280nm;柱温30℃;进样量20μl。结果在该色谱条件下,甲磺酸二氢麦角碱格峰与其相邻杂质峰能完全分离,在120～390μg/ml浓度范围内线性关系良好,r2=0.9996。结论该法简便、准确、专属性好,可以作为甲磺酸二氢麦角碱注射液中甲磺酸二氢麦角碱含量测定及有关物质检查。

Objective To establish the HPLC method for the determination of Dihydroergotoxine Methanesulfonate and its related substances in Dihydroergotoxine Methanesulfonate injection. Methods The HPLC system consisted of a Diamonsil C18 Column （200×4.6 mm ,5μm） , a mixture of water-aeetonitrile-triethylamine（62： 40： 2） as mobile phase; The flow rate：l, 5 ml/min, The detection wavelength：280 nm; The column temperature ：30℃. Results Dihydroergotoxine Methanesulfonate could be completely separately from other impurities. The linear range of Dihydroergotoxine Methanesulfonate was 20 - 390 μg/ml, r2 = 0, 999 6. Conclusion The method is simple, accurate and suitable for the determination of Dihydroergotoxine Methanesulfonate and related substances in Dihydroergotoxine Methanesulfonate injection.