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目的:检测克林霉素磷酸酯葡萄糖注射液高温灭菌后的药物成分。方法:采用UPLC-MS方法色谱条件:AcquityUPLC BEH C18(2.1 mm×50 mm,1.7μm)色谱柱,流动相乙腈-0.02M醋酸铵缓冲液(醋酸调pH 3.0),梯度洗脱,流速为0.25mL.min-1。质谱条件:电喷雾离子源(ESI),多反应检测(MRM)。结果:高温灭菌后的克林霉素磷酸酯葡萄糖注射液中检测到克林霉素磷酸酯、克林霉素和林可霉素,克林霉素为克林霉素磷酸酯葡萄糖注射液灭菌后的最大杂质。结论:此方法选择性强、灵敏度高,可作为分析灭菌后的克林霉素磷酸酯葡萄糖注射液中药物成分的检测方法。
OBJECTIVE: To determine the drug composition of clindamycin phosphate glucose injection after high temperature sterilization. Methods: The chromatographic conditions of UPLC-MS were as follows: AcquityUPLC BEH C18 (2.1 mm × 50 mm, 1.7 μm). The mobile phase consisted of acetonitrile-0.02 M ammonium acetate buffer mL.min-1. MS Conditions: Electrospray ionization (ESI), Multiple Reaction Detection (MRM). Results: Clindamycin phosphate, clindamycin and lincomycin were detected in clindamycin phosphate glucose injection after high temperature sterilization. Clindamycin was clindamycin phosphate glucose injection After sterilization of the largest impurities. Conclusion: This method is selective and sensitive and can be used as a method for the analysis of drug components in clindamycin phosphate-glucose injection after sterilization.