目的: 应用HPLC建立注射用美罗培南韦博巴坦的含量测定方法。方法: 采用Shimadzu InertSustain C18(150 mm×4.6 mm,5 μm)色谱柱,以乙腈-0.02 mol·L-1磷酸二氢钠溶液(用磷酸调pH至2.8)(10∶90)为流动相,流速1.0 mL·min-1,检测波长210 nm,进样体积10 μL。结果: 在本方法中,美罗培南和韦博巴坦的线性良好,线性范围分别为21.40~214.0 μg·mL-1和19.83~198.3 μg·mL-1;美罗培南和韦博巴坦精密度良好,RSD分别为0.17%和0.23%。24 h内,美罗培南和韦博巴坦在4 ℃条件下稳定性良好,RSD分别为0.31%和0.16%。美罗培南和韦博巴坦的平均加样回收率良好,分别为101.0%(n=9)和98.4%(n=9)(RSD均＜2.0%)。运用该方法测得该药品中美罗培南及韦博巴坦的含量分别为405.8、399.1 mg·g-1。结论: 该测定方法准确、简单、快速,可用于测定注射用美罗培南韦博巴坦的含量。
Objective: To develop a method for the determination of meropenem and vaborbactam for injection by HPLC. Methods: The chromatography was performed on Shimadzu InertSustain C18(150 mm×4.6 mm, 5 μm)column with acetonitrile-0.02 mol·L-1 sodium dihydrogen phosphate solution (adjust pH to 2.8 with phosphoric acid)(10∶90) as a mobile phase, the flow rate was 1.0 mL·min-1, the detection wavelength was 210 nm, and the sample volume was 10 μL. A method for the determination of meropenem and vaborbactam for injection was established under the chromatographic conditions. Results: In this method, the linearities of meropenem and vaborbactam were good, and the linearity ranges were 21.40-214.0 μg·mL-1 and 19.83-198.3 μg·mL-1. Meropenem and vaborbactam had good precision with RSD of 0.31% and 0.16%, respectively. Within 24 h, meropenem and vaborbactam had good stabilities at 4 ℃, RSDs were 0.31% and 0.16%, respectively. The average recoveries of meropenem and vaborbactam were 101.0%(n=9) and 98.4%(n=9) (RSD＜2.0%). The contents of meropenem and vaborbactam were 405.8 mg·g-1 and 399.1 mg·g-1, respectively. Conclusion: The method is accurate, simple and rapid, and can be used for the determination of meropenem and vaborbactam for injection.
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