高效液相色谱法测定注射用美罗培南韦博巴坦的含量

Determination of meropenem and vaborbactam for injection by high performance liquid chromatography

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 C_(18)(150 mm×4.6 mm,5μm)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10μL。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21.40~214.0μg·mL^(-1)和19.83~198.3μg·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 C_(18)(150 mm×4.6 mm,5μm)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 10μL.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 21.40-214.0μg·mL^(-1)and 19.83-198.3μg·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.