摘要
目的 建立HPLC法测定丹参素棕榈醇酯脂质体中药物含量的方法。方法 采用Agilent ZORBAX Eclipse Plus C 18 柱(4.6 mm×200 mm,5 μm);以乙腈-水(50∶50)含0.02%甲酸和0.02%三乙胺水、以pH 6~7的溶液为流动相,流速为1 ml/min,检测波长为280 nm,柱温为室温。结果 本色谱条件下丹参素棕榈醇酯与辅料及溶剂分离度符合要求,在 0.05~ 0.45 mg/ml范围内线性关系良好( r =0.999 5, n =5),回收率在96%~102%之间,日内及日间RSD均小于2%( n =5)。3批样品的含量分别为97.81%、101.20%、98.53%。结论 该方法准确可靠、简单快速,可用于丹参素棕榈醇酯脂质体含量的测定。
Objective To establish a HPLC method for the assay of palmitul 3-(3,4-dihydroxyphenyl)-2-hydroxypropanoate (PDSS) in liposomes. Methods The separation was performed with an Agilent ZORBAX Eclipse Plus C 18 column ( 4.6 mm ×200 mm,5 μm) at room temperature.The mobile phase was acetonitrile-aqueous solution (500 ml water + 0.1 ml triethylamine + 0.1 ml formic acid,pH=6-7)(50∶50) with the flow rate of 1 ml/min.Zidovudine palmitate was detected at 280 nm. Results PDSS had a good linear recovery between 0.05-0.45 mg/ml.The intra-day and inter-day RSD were <2%. The extracted recovery was in the range of 96% to 102%.The assay results for three batches were 97.81%,101.20% and 98.53%. Conclusion This method is simple,accurate and reliable.It can be used for the determination of PDSS in liposomes.
作者
王晶
张川
栗意
任金妹
唐扣明
WANG Jing;ZHANG Chuan;LI Yi;REN Jinmei;TANG Kouming(Department of Pharmacy,Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University,Shanghai 201700,China;Department of Medicine,Shanghai University,Shanghai 200003,China;Zhoupu Hospital Affiliated to Shanghai University of Medicine & Health Sciences,Shanghai 201318,China)
出处
《药学实践杂志》
CAS
2019年第5期450-452,480,共4页
Journal of Pharmaceutical Practice
基金
上海市卫生和计划生育委员会科研项目资助(20164Y0101)