米力农注射液中乳酸含量测定

Determination of Lactic Acid in Milrinone Injection

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p H=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 m L溶解后,加三乙胺2.4 m L,用磷酸调节p H=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 m L/min,检测波长为210 nm。结果表明,在198.16-1387.12μg/m L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- C18column（ 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 p H to 3. 0）, the mobile phase B consisted of dipotassium hydrogen phosphate solution（ taking dipotassium hydrogen 2. 7 g,adding water 800 m L dissolved and triethylamine 2. 4 m L,with phosphoric acid to adjust the p H to 7. 5）- acetonitrile（ 70 ∶30）,gradient elution,0 - 7min,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 m L / 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 / m L,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.