梯度洗脱高效液相色谱法测定马来酸麦角新碱原料及其片剂的含量和有关物质

Determination of content and related substances of ergonovine maleate and its tablets by gradient HPLC

目的:建立梯度洗脱高效液相色谱法测定马来酸麦角新碱原料和片剂有关物质检查方法。方法:采用梯度洗脱,用ODS-3(250 mm×4.6 mm,5μm)色谱柱,以0.015 mol·L^(-1)磷酸二氢钾溶液(磷酸调 pH 3.0)-乙腈(86:14)为流动相 A,0.015 mol·L^(-1)磷酸二氢钾溶液(磷酸调 pH 3.0)-乙腈(70:30)为流动相 B;流速:1.2 mL·min^(-1);检测波长:314 nm。结果:质量浓度在2.5～20.0μg·mL^(-1)内,马来酸麦角新碱线性关系良好(r=0.9998)。结论:本法简便、灵敏、专属,重现性好,结果准确可靠,可用于马来酸麦角新碱原料和片剂的含量和有关物质检测。

Objective：To establish a gradient elution HPLC method for determination of the contents and related substances in ergonovine maleate and its tablets. Method： The column was ODS - 3 （250 mm×4. 6 mm,5μm）. Mobile phase A ：0. 015 mol · L - 1 potassium dihydrogen phosphate buffer （ pH 3.0 ） ： acetonitrile was 86：14 ; Mobile phase B ：0. 015 mol · L-1 potassium dihydrogen phosphate buffer （pH 3.0） ： acetonitrile was 70： 30. Flow rate： 1.2 mL · min-1. Detection wavelength ：314 nm. Results：The calibration curve was linear in the range of 2. 5 -20.0 μg · mL - 1 （ r = 0. 9998 ）. Conclusion ： The method is simple, sensitive, specific, reproducible, accurate and suitable for examination of the eontens and related substances in ergonovine maleate and its tablets.