摘要
目的:建立同时测定恩再适注射液中4个主要成分咪唑丙烯酸、尿嘧啶、次黄嘌呤及黄嘌呤的高效液相色谱方法。方法:色谱柱为 Inertsil ODS 3柱(250 mm×4.6 mm,5 μm),流动相为甲醇-0.3%醋酸水溶液(1:99),流速:0.8 mL·min^(-1),柱温:25℃,检测波长:254 nm。结果:咪唑丙烯酸的线性范围为1.00～25.00μg·mL^(-1),平均回收率为101.5%;尿嘧啶的线性范围为0.995～19.50μg·mL^(-1),平均回收率为93.1%;次黄嘌呤的线性范围为0.20～5.00μg·mL^(-1),平均回收率为92.2%;黄嘌呤的线性范围为2.03～48.72μg·mL^(-1),平均回收率为97.0%。结论:本方法简便,准确,实现了多组分的快速同时测定,为制定恩再适注射液的质量标准提供了参考依据。
Objective ： To develop an HPLC method for the determination of urocanic acid, uracil, hypoxanthine and xanthine in Analgecine Injection. Method： The compounds were separated on an Inertsil ODS 3 column （250 mm × 4. 6 mm,5 μm） with a mobile phase of methanol - 0. 3 % acetic acid （ 1 ： 99）. The flow rate was 0. 8 mL·min^- 1 The column temperature was 25 ℃ and the detection was set at 254 nm. Results： The linear ranges were 1.00 - 25.00 μg·mL^-1,0.995 - 19.50 μg·mL^-1,0.20 - 5.00 μg·mL^-1 and 2.03 - 48.72μg·mL^-1 and the average recoveries were 101.5%, 93.1%, 92. 2% and 97.0% for urocanic acid, uracil, hypoxanthine and xanthine, respectively. Conclusion： This method is simple and accurate for the simultaneous determination of 4 components in Analgecine Injection. It can be used for the quality control of Analgecine Injection.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2007年第11期1732-1734,共3页
Chinese Journal of Pharmaceutical Analysis
