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目的:建立舒巴坦钠中舒巴坦青霉胺杂质含量的测定方法。方法:通过HPLC-UV法测定舒巴坦与舒巴坦青霉胺的标准曲线,以其斜率的比值表征二者的摩尔紫外吸收系数比值,并作为校正因子;在样品测定过程中,即可采用加校正因子的主成分自身对照法测定舒巴坦青霉胺杂质的含量。结果:舒巴坦与舒巴坦青霉胺的校正因子为0.30,RSD为2.6%(n=6);样品测定结果与JP收载的方法测定结果一致。结论:本法简便,准确,可作为舒巴坦钠的质量控制方法。
Objective: To establish a method for the determination of sulbactam penicillamine impurity in sulbactam sodium. Methods: The standard curve of sulbactam and sulbactam penicillamine was determined by HPLC-UV method. The molar ratio of UV absorption coefficient was expressed as the ratio of its slope, and used as the correction factor. During the sample determination, The content of sulbactam penicillamine impurity was determined by using the principal component self-control method with correction factor. RESULTS: The calibration factor for sulbactam and sulbactam penicillamine was 0.30 and the RSD was 2.6% (n = 6). The results of the samples were consistent with those of the methods described in JP. Conclusion: This method is simple, accurate and can be used as a quality control method of sulbactam sodium.