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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和含量的高效液相色谱法。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含量和有关物质。结论本方法测定注射用盐酸甲砜霉素甘氨酸酯含量灵敏度高、专属性强、线性范围宽、方法回收率好;测定其有关物质,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 substance and content of thiamphenicol hydrochloride glycinate for injection. Methods The octadecylsilane bonded silica gel was used as a filler. The pH was adjusted to 3.0 with phosphoric acid by using methanol-0.05mol / L potassium dihydrogen phosphate solution-triethylamine (20: 80: 0.05) Is 226 nm. Results The selected method can effectively detect the content of thiamphenicol hydrochloride glycinate and related substances. Conclusions The method for determination of thiamphenicol hydrochloride glycinate for injection has high sensitivity, specificity, wide linear range and good recovery rate. The determination of the related substances and the separation of impurity peaks from the principal component peaks are good, Effective detection of impurities, fully able to meet the quality control requirements.