摘要
目的建立HPLC法测定醋酸地塞米松原料的有关物质。方法采用Diamonsil C18(250 mm×4.6 mm,5μm)色谱柱,流动相:乙腈-水(体积比为40∶60),检测波长:254 nm,流速:1.0 mL·min-1,柱温:30℃,进样量:20μL。结果地塞米松、醋酸倍他米松、杂质A、杂质B、杂质C均在0.01~1.6mg·L-1内线性关系良好,平均回收率为91.0%~98.2%(n=9),RSD≤3.0%。结论醋酸地塞米松和有关物质可有效分离,可更好的控制醋酸地塞米松的质量。
Objective To establish an HPLC method for the determination of related substances of dexamethasone acetate.Methods The chromatography analysis was performed on an Diamonsil C18 column(250 mm×4.6 mm,5μm)with acetonitrile-water(V∶V=40∶60)as the mobile phase at a flow rate of 1.0 mL·min-1.The column temperature was 30℃and the detected wavelength was fixed at 254 nm.The injection volume was 20μL.Results Dexamethasone acetate and its related substances were effectively separated.The linear relationship of related substances was good in the range of 0.01-1.6 mg·L-1.Their recoveries for the related substances were 91.0%-98.2%(n=9),RSD≤3.0%.Conclusion This method is simple,efficient and accurate for the quantitation of the related substances in dexamethasone acetate.
作者
田晓彤
赵旻
徐艳梅
王淼
赵春杰
TIAN Xiaotong;ZHAO Min;XU Yanmei;WANG Miao;ZHAO Chunjie(School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China;Chemical Laboratory,Hebei Institute for Drug Control,Shijiazhuang 050200,China)
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2020年第3期252-256,267,共6页
Journal of Shenyang Pharmaceutical University
