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目的建立一种准确快速检测注射用盐酸甲砜霉素甘氨酸酯有关物质的高效液相色谱法并进行杂质归属研究。方法用十八烷基硅烷键合硅胶为填充剂;以甲醇-0.05mol/L的磷酸二氢钾溶液-三乙胺(20∶80∶0.05)用磷酸调节pH至3.0为流动相;检测波长为226nm。结果选用的方法能有效检测注射用盐酸甲砜霉素甘氨酸酯的有关物质,并对杂质进行了归属研究,同时对自制样品与市售样品的杂质水平进行了对比。结论本法测定注射用盐酸甲砜霉素甘氨酸酯有关物质,各杂质峰与主成分峰分离度较好,能保证各杂质有效检出,完全能够达到质量控制的要求。
OBJECTIVE To establish a high performance liquid chromatography (HPLC) method for the accurate and rapid detection of thiamphenicol hydrochloride glycinate ester for injection and study its impurity assignment. Methods The octadecylsilane bonded silica gel was used as a filler. The mobile phase was methanol-0.05mol / L potassium dihydrogen phosphate solution-triethylamine (20:80:0.05), phosphoric acid was used to adjust the pH to 3.0. The detection wavelength Is 226 nm. Results The selected method could effectively detect the related substances of thioamphhydrochloride glycinate for injection, and attribution studies of impurities were carried out. Meanwhile, the impurity levels of homemade samples and commercial samples were compared. Conclusion This method is suitable for the determination of thiamphenicol hydrochloride glycine ester for injection, and the separation of impurity peak and main component peak is good, which can ensure the effective detection of various impurities and fully meet the quality control requirements.