HPLC法测定米力农注射液中5-羟甲基糠醛的含量

Determination of 5-hydroxymethyfurfural in milrinone injection by HPLC

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,5μm）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p H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0.003~3.103μg/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。

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-CI8 col- unto （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.