刘敏*  李玉兰  杨敏  王玉

(深圳市药品检验所 , 深圳 518029)

摘要  目的:采用高效液相色谱法测定舒巴坦钠的有关物质。方法:以C₁₈为色谱柱，0.005mol•L^－1四丁基氢氧化铵溶液(pH5.0)-乙腈(75∶25)为流动相，流速为每分钟1ml，检测波长为230nm。结果: 舒巴坦钠的线性范围为0.22μg～109.5μg。结论:本法简便，准确，可作为舒巴坦钠的质量控制方法。

关键词  HPLC  舒巴坦钠  有关物质

HPLC Determination of Related Substances in Sulbactam Sodium

Liu Min , Li Yulan , Wang Yu

(ShenZhen City Institute for Drug Control , ShenZhen , 518029)

Abstract  Objective: To develop an HPLC method for determination of related substances in sulbactam sodium . Method: C₁₈ column was used. The mobile phase consisted of 0.005 mol•L^－1tetrabutylammonium hydroxide(pH5.0) – acetonitrile (75∶25), the flow rate was 1.0ml•min^-1. The UV detector wavelength was 230nm. Results:    The calibration curves showed good linearity in the range of 0.22μg～109.5μg. Conclusion: This method developed is convenient and reliable and could be used for quality control of sulbactam sodium.

Key  words    HPLC;  sulbactam sodium; related substances