摘要
目的:建立适用于依达拉奉注射液中抗氧剂亚硫酸氢钠含量测定的HPLC法.方法:使用Thermo C_(18)色谱柱(250 mm×4.6 mm,5μm),柱温为30℃,离子对溶液(取四丁基硫酸氢铵10.19 g和磷酸二氢钾1.36 g,加水溶解定容至1000 mL,用40%氢氧化钠溶液调节pH至6.0)-乙腈(80:20)为流动相,流速为1.0 mL·min^(-1),检测波长为215 nm,进样量为20μL.结果:亚硫酸氢钠与其他峰分离良好,在0.25~1.50μg·mL^(-1)浓度范围内,线性关系良好.平均回收率为99.49%,精密度、耐用性良好.结论:所建方法简单、准确,适用于依达拉奉注射液的质量评价与控制.
Objective:To establish an HPLC method for determination of sodium bisulfite,an antioxidant in edaravone injection.Methods:The test for sodium bisulfate was performed on the Thermo C_(18)(250 mm×4.6 mm,5μm)column.The column temperature was 30℃.The mobile phase was ion-pair solution(dissolving 10.19 g tetrabutylammonium sulfate and 1.36 g potassium dihydrogen phosphate with water to 1000 mL,adjusting pH to 6.0 with 40%sodium hydroxide solution)-acetonitrile(80∶20).The flow rate was 1.0 mL·min^(-1),detection wavelength was 215 nm,and the sample injection volume was 20μL.Results:The separation of sodium bisulfite from other peaks was good.A good linearity was observed over the range of 0.25~1.50μg·mL^(-1).The average recovery rate was 99.49%,and the precision and durability were good.Conclusion:The method is simple and accurate,and it is suitable for the quality evaluation and control of edaravone injection.
作者
张驰
韩遵圣
刘博
吴松
ZHANG Chi;HAN Zun-sheng;LIU Bo;WU Song(Institute of Materia Medica.Chinese Academy of Sciences and Peking Union Medical College,Beijing 100050,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2022年第8期802-806,共5页
Chinese Journal of New Drugs
基金
中国医学科学院医学与健康科技创新工程重大协同创新项目(2017-12M-1-011)。
