高效液相色谱法定注射用亚胺培南西司他丁钠含量.docVIP

高效液相色谱法测定注射用亚胺培南西司他丁钠含量 刘刚1，周倩怡2，李进利1，兰青1，姜韧1，张华1，谭生建1*（1.中国人民解放军第306医院 药学部 北京 100101； 2.佳木斯大学化学与药学院 佳木斯 154000） 摘要 ： 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（250 mm ×4.6 mm ，5 μm），柱温30℃，流动相为乙腈–0.1%磷酸（50 ：50)，流速1mL/min，检测波长265 nm。结果 亚胺培南和西司他丁钠的理论板数分别约为9000和9500，与相邻峰的分离度均大于1.5。以峰面积（X）对进样浓度（Y，μg/mL）线性回归，亚胺培南的回归方程：Y=0.6386X+6.173，r为0.9999，线性范围117.1～585.5 μg/mL；西司他丁钠的回归方程：Y=0.5886X+6.294，r为0.9999，线性范围117.1～585.3 μg/mL。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。 关键词：高效液相色谱法；亚胺培南；西司他丁钠 中图分类号：R927.1 文献标识码：A 文章编号：2008- Determination of Imipenem and Cilastin for Injection Sodium by HPLC LIU Gang = 1 \* GB3 ①,ZHOU Qian-yi = 2 \* GB3 ②，LI Jin-li = 1 \* GB3 ① ,LAN Qing, JIANG Ren = 1 \* GB3 ①，ZHANG Hua = 1 \* GB3 ① ,TAN Sheng-jian = 1 \* GB3 ①*（ = 1 \* GB3 ①department of Pharmacy， Hospital 306 of PLA，Beijing 100101 China ， = 2 \* GB3 ②college of Chemistry and Pharmacy, Jiamusi university, Jiamusi 154000 China ） ABSTRACT: OBJECTIVE To establish an HPLC quantitative method for the determination of Imipenem and Cilastin Sodium for Injection . METHOD The chromatographic conditions include CN column(250 mm ×4.6 mm，5 μm) , temperature 30°C, acetonitrile–0.1% phosphoric acid(50:50) as mobile phase . The flow rate was 1ml/min and monitored at 265 nm. RESULTS The theoretical plate number of Imipenem is 9000, and that of Cilastin Sodium is 9500.The resolution is more than 1.5. The regress equation for Imipenem was Y=0.6386X+6.173 , r=0.9999 and the linear range was 117.1～585.5μg/mL;Cilastin Sodium Y=0.5886X+6.294, r=0.9999,and the linear range was 117.1～585.3μg/mL.The average recovery (RSD)of Imipenem , Cilastin Sodium were 98.8% (1.7%) and 99.2%(1.1%) respectively. CONCLUSIONS The method is precise, accurate, simple, and can be applied to determin the content of Imipenem and Cilastin Sodium for Injection. KEY WORDS: HPLC ; Imipenem; Cilastin Sodium 注射用亚胺培南西司他丁钠由β-内酰胺类抗生素亚胺培南和肾肽酶抑制剂西司他丁钠加碳酸氢钠为辅料混合而成，