利福霉素钠原料及其注射剂杂质谱分析

目的：探讨利福霉素钠原料和注射剂的杂质控制策略。 方法：采用高效液相色谱法，色谱柱为Agilent Zorbax SB C₁₈（4.6 mm×250 mm，5 μm），以0.39%磷酸二氢钠溶液（pH 7.5）-乙腈为流动相，梯度洗脱，流速1.0 mL·min^-1，柱温35℃，检测波长254 nm，进样量20 μL；通过破坏性试验、影响因素试验、配伍试验、加速试验以及原料和制剂杂质谱的测定，分析利福霉素钠原料和注射剂的杂质来源及其影响因素。 结果：利福霉素钠原料的有关物质主要为利福霉素S和未知杂质1、2、3、5、6，注射剂的有关物质主要为未知杂质1、2、3，其中6为降解杂质，利福霉素S和未知杂质1、2、3和5为固有杂质，另外有很多含量较少的其他未知杂质，杂质谱比较恒定。破坏性试验、影响因素试验和加速试验表明温度是影响杂质含量的重要因素。 结论：通过对利福霉素钠及其注射剂杂质谱的研究，分析了杂质的来源及其影响因素，可以有目的地控制一些杂质，为质量控制提供参考；同时可以分析其样品来源，为日常质量监督提供参考。

Objective: To discuss the impurity control strategy of rifamycin sodium and its injection. Methods: To analyze the source and influencing factor of impurities of rifamycin sodium and its injection by destroy testing,compatibility testing,stress testing,accelerating testing and the related substances results of rifamycin sodium injection from evaluative testing.HPLC separation was carried out with an Agilent Zorbax SB C₁₈ column(4.6 mm×250 mm,5 μm),using 0.39% phosphate dihydrogen sodium solution-acetonitrile gradient elution system,the flow rate was 1.0 mL·min^-1,the column temperature was 35℃,the detection wavelength was 254 nm and the injection volume was 20 μL. Results: The impurities of rifamycin sodium contain rifamycin S and unknown impurity 1,2,3,5,6,and the impurities of injection contain unknown impurity 1,2,3.Among them the impurity 6 is from degradation,rifamycin S and the unknown impurity 1,2,3,5 are inherent impurity,and there are other little unknown impurities.The temperature is the main factor to influence the content of impurity by destructive testing,stress testing and accelerating testing. Conclusion: To analyze the source and influencing factor of impurities through the study on the impurity profiles of rifamycin sodium and its injection,thus the impurities can be controled,which provides reference for the quality control of rifamycin sodium injection.

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