HPLC测定米力农的含量及有关物质

Determination of Milrinone and its related substances by HPLC

目的采用HPLC法测定米力农中的含量及有关物质。方法采用Ultimate XB—C18（250mm×4．6mm，5μm）色谱柱，以甲醇-水-0．05moL·L^-1硼砂缓冲液（磷酸调pH7．0）（280：700：20）为流动相，检测波长268nm，流速1．0mL·min^-1。结果米力农的色谱峰与各杂质峰的分离良好，米力农7，944～79．44μg·mL^-1与峰面积呈良好的线性关系（r=0．9996）；检测限、定量限分别为66．87μg·mL^-1和0．2006ng·mL^-1；含量测定及其有关物质检查的中间精密度RSD分别为0．31％、3．98％。结论所用方法准确、灵敏，精密度高，专属性强，适用于米力农的含量测定和有关物质检查。

OBJECTIVE To establish an RP - HPLC method for determination of Milrinone and its related substances. METHODS The analytical column was Ultimate XB - C18（250 mm × 4.6 mm ,5 μm）. The mobile phase consisted of 0.05 moL·L^-1 borate buffer solution （ adjusting pH to 7.0 with phosphoric acid） - water - methanol（20 ： 700 ： 280）. The detection wavelength was 268 nm and the flow rate was 1.0 mL. min^-1 RESULTS A good separation for Milrinone and the other impurities was achieved. The calibration curve of Milriuone was linear（ r = 0. 9996, n = 6 ） within the range of 7. 944 - 79.44 μg·mL^-1. Quantitation limit and detection limit was 66. 87μg·mL^-1 and 0. 2006 ng·mL^-1 ,respectively,and the intermediate precision RSD were 0.31% and 3.98% in the content and related substance determination. CONCLUSION The method was proved to he accurate, sensitive and precise and showed highly specific. It can be applied for testing the content assay of Milrinone, as well as the related substances of Milrinone.