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目的:优化美罗培南及注射用美罗培南含量测定的色谱条件。方法:以0.1%三乙胺溶液-乙腈(93.5:6.5)为流动相;以0.1%三乙胺溶液为溶剂;色谱柱为C_(18),柱温30℃;系统适用性检测波长220 nm,检测波长300 nm;调整美罗培南主峰保留时间为5～7 min,流速1.0 ml·min~(-1)。结果:美罗培南的线性范围为50.11～751.68μg·ml~(-1)(r=0.9999);美罗培南平均回收率为101.1%(RSD=1.0%,n=9);注射用美罗培南平均回收率为100.8%(RSD=1.0%,n=9)。结论:本方法灵敏、简便、快速、准确、可用于美罗培南及注射用美罗培南的含量测定。
OBJECTIVE: To optimize the chromatographic conditions for the determination of meropenem and meropenem for injection. Methods: The mobile phase consisted of 0.1% triethylamine solution - acetonitrile (93.5: 6.5) and 0.1% triethylamine as solvent. The column was C 18 and the column temperature was 30 ℃. The detection wavelength was 300 nm. The retention time of meropenem main peak was 5 ~ 7 min and the flow rate was 1.0 ml · min ~ (-1). Results: Meropenem’s linear range was 50.11-751.68μg · ml -1 (r = 0.9999). The average recovery of meropenem was 101.1% (RSD = 1.0%, n = 9). Meropenem for injection was recovered on average The rate was 100.8% (RSD = 1.0%, n = 9). Conclusion: The method is sensitive, simple, rapid and accurate and can be used for the determination of Meropenem and Meropenem for injection.