高效液相色谱法测定注射用亚胺培南西司他丁钠含量

 目的建立正相高效液相色谱法测定注射用亚胺培南西司他丁钠的含量。方法色谱柱用氰基柱(4.6mm×250mm, 5μm),柱温30℃,流动相为乙腈-0.1%磷酸(50:50),流速1 mL·min^-1,检测波长265 nm。结果亚胺培南和西司他丁钠的理论塔板数分别约为9 000和9 500,与相邻峰的分离度均大于1.5。以峰面积(X)对进样浓度(Y,mg·L^-1)线性回归,亚胺培南的回归方程:Y=0.638 6X+6.173,r=0.999 9,线性范围117.1～585.5 mg·L^-1;西司他丁钠的回归方程:Y= 0.588 6X+6.294,r=0.999 9,线性范围117.1～585.3 mg·L^-1亚胺培南和西司他丁钠的回收率(RSD)分别为98.8%(1.7%)和99.2%(1.1%)。结论本方法精密度和准确度好,操作简便,可用于测定注射用亚胺培南西司他丁钠中亚胺培南和西司他丁钠的含量。

Determination of Imipenem and Cilastatin for Injection Sodium by HPLC

OBJECTIVE To establish a HPLC quantitative method for the determination of imipenem and cilastatin sodium for Injection.METHODS The separation was performed on a CN column(4.6 mm×250 mm,5μm) with mobile phase of acetonitrile -0.1%phosphoric acid(50:50) at the flow rate of 1 mL·min^-1.The determination wavelength was at 265 nm.The column temperature was at 30℃.RESULTS The theoretical plate number of imipenem was 9 000,and that of cilastin sodium was 9 500.The resolution was more than 1.5.The regression equation for imipenem was Y=0.638 6X+6.173(r=0.999 9),and the linear range was 117.1-585.5 mg·L^-1.The regression equation of cilastin sodium was Y=0.588 6X+6.294(r=0.999 9),and the linear range was 117.1-585.3 mg·L^-1.The average recoveries of imipenem and cilastin sodium were 98.8%(1.7%) and 99.2%(1.1%), respectively.CONCLUSION The method is precise,accurate,simple,and can be applied to determin the content of Imipenem and Cilastin Sodium for Injection.