摘要
目的优化《中国药典》2020年版盐酸表柔比星有关物质测定方法。方法取多柔比星酮3mg,置10ml量瓶中,加DMSO溶解并稀释至刻度,摇匀。取盐酸多柔比星3mg和盐酸表柔比星10mg,置10ml量瓶中,加流动相溶解并稀释至刻度,摇匀。分别精密量取上述两种溶液各5ml,置50ml量瓶中,用流动相稀释至刻度,摇匀,即得。结果优化后的方法,系统适用性溶液色谱图中多柔比星酮、多柔比星和表柔比星的保留时间与原系统适用性溶液中的一致且稳定,各峰的理论板数>2000,与相邻峰的分离度>1.5,满足系统适用性要求,对测定无干扰。结论优化后的方法可解决《中国药典》2020年版收载的盐酸表柔比星有关物质方法中系统适用性溶液中多柔比星酮溶解问题,且方法准确、耐用性好,适用于盐酸表柔比星有关物质的测定。
Objective To optimize the determination method of related substances of Epirubicin hydrochloride in the Chinese Pharmacopoeia 2020.Methods Take 3mg of doxorubicinone,put into a 10ml volumetric flask,add DMSO to dissolve and dilute to the scale.Take 3mg of doxorubicin hydrochloride and 10mg of epirubicin hydrochloride,put into a 10ml volumetric flask,add mobile phase to dissolve and dilute to the scale,and shake well.Accurately measure 5ml of each of the above two solutions,put into a 50ml volumetric flask,dilute with mobile phase to the scale,and shake well.Results The retention time of doxorubicinone,doxorubicin and epirubicin in the chromatogram of the system suitability solution is consistent and stable with that in the original system suitability solution.The number of theoretical plates of each peak is more than 2000,and the resolution of adjacent peaks is more than 1.5,which meets the system suitability requirements and has no interference to the determination.Conclusion The optimized method can solve the problem of dissolution of doxorubicinone in the system suitability solution in the method of epirubicin hydrochloride related substances contained in the Chinese Pharmacopoeia 2020.The optimized method is accurate,durable and suitable for the determination of related substances of epirubicin hydrochloride.
作者
宋丽
张家宁
车慧
何丽娟
Song Li;Zhang Jianing;Che Hui;He Lijuan(Beijing Union Pharmaceutical Factory Ltd,Beijing 102600,China)
出处
《首都食品与医药》
2023年第12期147-150,共4页
Capital Food Medicine
关键词
盐酸表柔比星
多柔比星酮
有关物质
系统适用性溶液
Epirubicin hydrochloride
Doxorubicinone
Related substances
System suitability solution
