标题：HPLC法测定米力农注射液中5-羟甲基糠醛的含量

      作者：朱正兵，梅泽胜
    (海南灵康制药有限公司，海南 海口 570311)

      卷次： 2015年26卷9期

      【摘要】 目的 建立米力农注射液中5-羟甲基糠醛的含量测定方法。方法 高效液相色谱法，采用ODS-C18
(4.6 mm×250 mm，5 ?m)色谱柱，磷酸氢二钾溶液(取磷酸氢二钾2.7 g，加水800 ml溶解后加三乙胺2.4 ml，用磷酸调
节pH值至 7.5)-乙腈(85：15)为流动相，流速 1.0 ml/min，检测波长为 284 nm。结果 在 0.003~3.103 μg/ml范围
内 5-羟甲基糠醛的峰面积与浓度具有良好的线性关系，相关系数 r=0.999 9，平均回收率为 99.50，RSD为
0.98%。结论 本方法准确，可靠，重复性好，可作为米力农注射液中5-羟甲基糠醛的质量控制方法。

      【关键词】 高效液相色谱法；米力农注射液；5-羟甲基糠醛；含量

      【中图分类号】 R972+.1 【文献标识码】 A 【文章编号】 1003—6350（2015）09—1373—03


Determination of 5-hydroxymethyfurfural in milrinone injection by HPLC.
ZHU Zheng-bing, MEI Ze-sheng.
Hainan Ling Kang Pharmaceutical Co., Ltd., Haikou 570311, Hainan, CHINA

【Abstract】 Objective To establish an assay for determination of 5-hydroxymethyl furfural in milrinone in-
jection by high performance liquid chromatography (HPLC). Methods HPLC was carried out on a ODS-C18 col-
umn (4.6 mm×250 mm, 5 μm), with potassium phosphate dibasic solution-acetonitrile (85:15) as the mobile phase, the
flow rate of 1.0 ml/min and the detection wavelength of 284 nm. Potassium phosphate dibasic solution was prepared
by dissolving 2.7 g potassium phosphate dibasic in 800 ml water, followed by adding 2.4 ml triethylamine, which were
then adjusted to pH 7.5 with phosphoric acid. Results The standard curve was in good linearity in the range of
0.003~3.103 μg/ml for determination of its related substances (r=0.999 9). The average recovery was 99.45%, with
RSD of 1.02%. Conclusion The method is accurate, reliable, reproducible and can be used for quality control of
5-hydroxymethyfurfural in milrinone injection.

      【Key words】 High performance liquid chromatography (HPLC); Milrinone injection; 5-hydroxymethyl furfu-