HPLC法测定注射用伏立康唑中倍他环糊精的含量  

Determination of Beta-cyclodextrin in Voriconazole for Injection by HPLC

作　　者：赵萌 朱明儒 ZHAO Meng;ZHU Mingru(Jilin Institute for Drug Control,Changchun 130000,China)

机构地区：[1]吉林省药品检验研究院,吉林长春130000

出　　处：《品牌与标准化》2023年第5期102-104,共3页

摘　　要：目的:建立注射用伏立康唑制剂中倍他环糊精含量测定方法,考察该制剂中倍他环糊精的影响因素。方法:参考《中华人民共和国药典(2020年版)》四部羟丙基倍他环糊精中有关物质测定方法,采用HPLC,示差折光检测器测定倍他环糊精,参考《中华人民共和国药典(2020年版)》四部原料药物与制剂稳定性试验指导原则建立影响因素试验。结果:建立测定方法并对该方法进行方法学验证,结果该方法专属性好、检测限和定量限满足测定要求、线性关系良好、准确度高,方法可行,影响因素试验中高温条件下倍他环糊精含量明显增加。结论:本方法为注射用伏立康唑中倍他环糊精的含量测定提供参考,影响因素试验提示企业在生产及贮存过程中应关注温度变化。Objective:To establish a method for the determination of beta-cyclodextrin in voriconazole for injection,and investigate the influencing factors of beta-cyclodextrin in the preparation.Methods:Referring to the determination method of related substances in hydroxypropyl beta-cyclodextrin in the fourth part of the "Chinese Pharmacopoeia 2020 edition",the beta-cyclodextrin was determined by HPLC and differential refractive detector,and the influence factor test was established by referring to the guiding principles of the stability test of raw materials and preparations in the fourth part of the "Chinese Pharmacopoeia 2020 edition".Results:The determination method was established and its methodology was verified.The results showed that the method was specific,the detection limit and the limit of quantification met the determination requirements,the linear relationship was good,the accuracy was high,and the method was feasible.The content of beta-cyclodextrin was significantly increased under high temperature in the influence factor test.Conclusion:This method provides a reference for the determination of beta-cyclodextrin in voriconazole for injection,and the test of influencing factors suggests that enterprises should pay attention to temperature changes during production and storage.

关 键 词：倍他环糊精 示差检测器 注射用伏立康唑 影响因素 

分 类 号：TQ460.72[医药卫生—药物分析学] O657.72[化学工程—制药化工]