建立了米力农注射液中乳酸含量测定方法。高效液相色谱法,采用ODS-C18(4.6 mm×250 mm,5μm)色谱柱,以0.05 mol/L磷酸二氢钾溶液(用磷酸调节pH=3.0)为流动相A；以磷酸氢二钾溶液(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=7.5)-乙腈(70：30)为流动相B,进行梯度洗脱,0~7 min、7~8 min、8~15 min、15~16 min、16~27 min 的流动相分别为：流动相 A：100%,流动相 B：0→100%,流动相 B：100%,流动相 A：0→100%,流动相 A：100%；流速1.0 mL/min,检测波长为210 nm。结果表明,在198.16~1387.12μg/mL范围内乳酸的峰面积与浓度具有良好的线性关系,相关系数r=0.9998,平均回收率为100.42%, RSD为0.89%。本方法准确,可靠,重复性好,可作为米力农注射液中检测乳酸含量的质量控制方法。%To establish an assay of determination of lactic acid in milrinone injection, HPLC was carried out on a ODS-C18 column (4. 6 mm×250 mm, 5 μm) column, the mobile phase A consisted of 0. 05 mol/L potassium dihydrogen phosphate solution(with phosphoric acid to adjust the pH to 3. 0), the mobile phase B consisted of dipotassium hydrogen phosphate solution( taking dipotassium hydrogen 2. 7 g, adding water 800 mL dissolved and triethylamine 2. 4 mL, with phosphoric acid to adjust the pH to 7. 5)-acetonitrile (70:30), gradient elution, 0~7 min, 7~8 min, 8~15 min, 15~16 min, 16~27 min of the mobile phase were as follows: mobile phase A: 100%, mobile phase B: 0→100%, mobile phase B: 100%, mobile phase A: 0→100%, mobile phase A: 100%, with the flow rate of 1. 0 mL/min, the detection wavelength was 210 nm. The results showed that the standard curve was in good linearity in the range of 198. 16~1387. 12 μg/mL, r=0. 9998 for determination of its related substances. The average recovery was 100. 42%, RSD was 0. 89%. The method is accurate, reliable, reproducible and can be used for quality control of lactic acid in milrinone injection.
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