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目的:建立一种测定美罗培南中间体美罗培南侧链异构体的含量的正相高效液相方法。方法:waters配VWD检测器,手性色谱柱Chiralpak AS-H,流动相为正己烷:异丙醇:乙醇=400:50:50(v/v/v),VWD检测器,波长为260nm,流速为1.0mL·min~(-1),柱温为30℃,样品浓度0.4mg·mL~(-1),进样量20uL。结果:美罗培南侧链与美罗培南侧链异构体的分离度为15.7,重复性RSD%=4.9%,美罗培南侧链异构体在0.03~1.8ug·mL~(-1)线性范围标准曲线y=2.15613×10-5x+0.0310527(R2=0.9995),回收率在99.3%~102.1%之间,最小检测量为0.03ug·mL~(-1),最小检测限度为0.009ug·mL~(-1)。结论:该方法专属性好,灵敏度高,简单快捷,能有效控制美罗培南培南侧链异构体的含量。
OBJECTIVE: To establish a method for the determination of meropenem side chain isomers in meropenem. Methods: Waters were equipped with a VWD detector and a Chiralpak AS-H chiral column. The mobile phase consisted of n-hexane: isopropanol: ethanol = 400: 50:50 v / v / The flow rate was 1.0 mL · min ~ (-1), the column temperature was 30 ℃, the concentration of the sample was 0.4 mg · mL -1, and the injection volume was 20 uL. Results: The separation of meropenem side chain and meropenem side chain isomers was 15.7%, repeatability RSD% = 4.9% and meropenem side chain was in the range of 0.03 ~ 1.8ug · mL -1 The curve y = 2.15613 × 10-5x + 0.0310527 (R2 = 0.9995). The recoveries ranged from 99.3% to 102.1%. The minimum detection limit was 0.03ug · mL -1. The minimum detection limit was 0.009ug · mL ~ (-1). Conclusion: The method is characterized by good specificity, high sensitivity, simple and quick, and can effectively control the southern side chain isomer content of Meropenem.