摘要
目的 :开展HPLC-ELSD法测定丙泊酚中/长链脂肪乳注射液中溶血磷脂酰胆碱(LPC)和溶血磷脂酰乙醇胺(LPE)的方法学验证。方法 :参照国家药典委员会颁布的丙泊酚乳状注射液征求意见稿项下LPC和LPE的分析方法进行验证。结果:LPC在20.56~411.12 mg/ml(R=0.999 8),LPE在5.79~115.71 mg/ml(R=0.999 4)范围内线性良好;他们的定量限浓度分别为23.1 mg/ml、10.3 mg/ml,检测限浓度分别为9.2 mg/ml、4.1 mg/ml。两者加样回收率RSD分别为0.7%、8%;方法重复性、耐用性好。结论 :本检测方法专属性强,结果可靠,重复性好,可用于丙泊酚中/长链脂肪乳注射液的质量评价。
Objective:To verify the HPLC-ELSD method for the determination of lysophosphatidyl choline(LPC)and lysophosphatidyl ethanolamine(LPE)in propofol medium and long chain fat emulsion injection.Methods:The method was verified based on a manuscript of request for comments on propofol emulsion injection by Chinese Pharmacopoeia Commission.Results:The standard curves were linear over the range of 20.56-411.12 mg/ml(R=0.9998)for LPC and 5.79-115.71 mg/ml(R=0.9994)for LPE.Their quantification limits,detection limits and relative standard deviations(RSD)were 23.1 mg/ml,9.2 mg/ml and 0.7%for LPC and 10.3 mg/ml,4.1 mg/ml and 8%for LPE,respectively.The durability and repeatability of the method were good.Conclusion:The method is accuracy,effective and can be used for the quality control of propofol medium and long chain fat emulsion injection.
作者
丁丽燕
郑娟
朱晓晓
DING Liyan;ZHENG Juan;ZHU Xiaoxiao(Shanghai Joy Biopharm CO.,LTD.,Shanghai Engineering Research Center of Lipid Emulsion,Shanghai 201203,China)
出处
《上海医药》
CAS
2020年第11期98-102,共5页
Shanghai Medical & Pharmaceutical Journal
关键词
丙泊酚中/长链脂肪乳注射液
溶血磷脂酰胆碱
溶血磷脂酰乙醇胺
propofol medium and long chain fat emulsion injection
lysophosphatidyl choline
lysophosphatidyl ethanolamine
