注射用甲泼尼龙琥珀酸钠有关物质的HPLC检查条件研究  

Study on HPLC Detection of Related Substances in Methylprednisolone Sodium Succinate for Injections

作　　者：赵砚荣[1] ZHAO Yanrong(Jiangsu Aosaikang Pharmaceutical Co.,Ltd.,Nanjing 211112,China)

机构地区：[1]江苏奥赛康药业有限公司,南京211112

出　　处：《药学与临床研究》2025年第1期62-64,共3页Pharmaceutical and Clinical Research

摘　　要：目的:建立注射用甲泼尼龙琥珀酸钠的有关物质测定方法。方法:采用HPLC法,色谱柱为Diamonsil C18(2)柱(250 mm×4.6 mm,5μm)。流动相为水(用磷酸调节pH值至2.5)-乙腈(70∶30),柱温40℃,流速1.0 ml·min^(-1),检测波长254 nm。结果:各杂质峰与甲泼尼龙琥珀酸峰均能达到基线分离,甲泼尼龙琥珀酸峰与相邻峰的分离度均大于>2.0,理论塔板数>5000,方法的精密度RSD为0.04%,检测限为0.87 ng。结论:建立的注射用甲泼尼龙琥珀酸钠有关物质检查方法,专属性强,准确、快速,可用于注射用甲泼尼龙琥珀酸钠的有关物质质量控制。Objective:To establish an HPLC method for determining related substances in methylpred-nisolone sodiunm succinate for injections.Methods:The HPLC method used a Diamonsil C18(2)(250 mm×4.6 mm,5μm)column.The mobile phase was water(phosphate regulating pH value to 2.5)-acetonitrile(70∶30).The column temperature was 40℃.The flow rate was 1.0 mL·min^(-1).The detection wavelength was set at 254 nm.Results:The chromatographic peaks of impurities and methylprednisolone succinate reached baseline separation with peak separation degrees greater than 2.0,the number of theoretical plates was greater than 5000.The precision RSD of the method was 0.04%and the detection limit was 0.87 ng.Con-clusion:The method appeared to be specific,accurate and rapid,and can be used for the quality control of related substances in methylprednisolone sodium succinate for injections.

关 键 词：注射用甲泼尼龙琥珀酸钠 有关物质 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]