HPLC法测定酮咯酸氨丁三醇双相控释片的含量
Content Determination of Ketorolac Tromethamine Biphasic Controlled Release Tablet by HPLC Method
李玉靓 1曾媛 2彭瑛 3陈志龙 2方松 2石林 2刘辉2
作者信息
- 1. 430065 湖北武汉,武汉科技大学医学部医学院
- 2. 中部战区总医院医疗保障中心
- 3. 陆军第七十四集团军医院泌尿外科
- 折叠
摘要
目的 采用高效液相色谱(high performance liquid chromatography,HPLC)法测定酮咯酸氨丁三醇(ke-torolac tromethamine,KT)双相控释片中 KT 的含量.方法 HPLC 法色谱柱为 DIKMA C18(250 mm× 4.6 mm,5μm);流动相:甲醇-水-冰醋酸(65∶34∶1);检测波长:318nm;液相流速:0.90 ml/min;柱温:40℃;进样量:20 μl.结果 KT浓度在5～400 μg/ml时,线性关系良好(R2=0.9998);速释层平均回收率为102.27％,相对标准偏差(relative standard de-viation,RSD)为0.93％,控释层平均回收率为100.37％,RSD为0.18％;KT双相控释片速释层和控释层的含量均匀度均符合中国药典规定.结论 本研究所建立的KT双相控释片含量测定方法专属性强、重现性良好、结果准确,可以用于该双相控释片的质量控制.
Abstract
Objective To use high performance liquid chromatography(HPLC)method for the determination of the content of ketorolac tromethamine(KT)in KT biphasic controlled release tablet.Methods The HPLC column was DIKMA C18(250 mm× 4.6 mm,5 μm);mobile phase:methanol-water-glacial acetic acid(65∶34∶1);detection wave-length:318 nm;liquid-phase flow rate:0.90ml/min;column temperature:40 ℃;injection volume:20 μl.Results The concentration of KT at 5-400 μg/ml showed good linearity(R2=0.9998);the average recovery of immediate-release lay-er was 102.27％,the relative standard deviation(RSD)was 0.93％,the average recovery of controlled-release layer was 100.37％,and RSD was 0.18％;the content homogeneity of KT biphasic controlled release tablet in the immediate-release layer and in the controlled-release layer were in compliance with the pharmacopoeia regulations.Conclusion The specificity of the method for the determination of KT biphasic controlled release tablet established in this study is strong,the reproducibility is good and the results are accurate,which can be used for the quality control to the biphasic controlled release tablet.
关键词
酮咯酸氨丁三醇/双相控释片/高效液相色谱法/质量控制Key words
Ketorolac tromethamine/Biphasic controlled release tablet/High performance liquid chromatography/Quality control引用本文复制引用
出版年
2024
NETL
NSTL
万方数据