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目的:建立注射用亚胺培南西司他丁钠聚合物的测定方法。方法:柱温为室温;对照品采用西司他丁铵盐。结果:注射用亚胺培南西司他丁钠在40.40～160.55mg/mL,(r=0.9999)浓度范围内与聚合物的峰面积呈良好线性关系。结论:方法简便,结果可靠,可以用于注射用亚胺培南西司他丁钠中高分子聚合物杂质的检测。
Objective: To establish a method for the determination of imipenem and cilastatin sodium for injection. Methods: The column temperature was room temperature; the reference substance was cilastatin ammonium salt. RESULTS: Imipenem Cilastatin sodium for injection showed a good linear relationship with the peak area of polymer in the concentration range of 40.40 ~ 160.55mg / mL (r = 0.9999). Conclusion: The method is simple and reliable. It can be used for the determination of high molecular weight polymer impurities in imipenem and cilastatin sodium for injection.