高效液相色谱法测定呋喃烯啶原料药含量
Content determination of Raw Materials of Furagin by High Performance Liquid Chromatography
宋子君 1潘雪飞 2徐欣昌1
作者信息
- 1. 310009 浙江杭州,杭州市第三人民医院
- 2. 311121 浙江杭州,杭州师范大学药学院
- 折叠
摘要
目的 测定呋喃烯啶原料药含量,以对其质量进行控制.方法 采用高效液相色谱法,色谱柱为 WondaCract ODS-2(4.6 mm×250 mm,5 μm),流动相为水(磷酸调节水相pH 4.0)-乙腈(60∶40),流速为1.0 ml·min-1,柱温为30℃,检测波长为292 nm,进样量为20 μl,运行时间为30 min,平衡时间为20 min.结果 呋喃烯啶线性范围为0.1～0.8 mg·ml-1(r=0.999 7);在专属性考察中,呋喃烯啶与其降解物质分离良好;仪器精密度试验RSD为0.46%(n=6),重复性试验RSD为0.41%(n=6);平均回收率为100.6%,RSD为0.97%(n=9).结论 该方法操作简便、灵敏度高、分离度好、结果准确,可作为呋喃烯啶原料药质量控制的方法.
Abstract
Objective To determine the contents of active pharmaceutical ingredients in raw materi-als of furagin by high performance liquid chromatography in order to contribute to quality control.Methods The column was a WondaCract ODS-2(4.6 mm×250 mm,5 μm),the mobile phase was water(pH 4.0,the aqueous phase adjusted by phosphoric acid)-acetonitrile(60∶40),the flow rate was 1.0 ml·min-1,the column temperature 30℃,the detection wavelength 292 nm,the injection volume 20 μl,the running time 30 min,and the duration of equilibration was 20 min.Results The linear range of furagin was 0.1-0.8 mg·ml-1(r=0.9997).Furagin was well separated from its degraded substances in the specificity test.The RSD was 0.46%(n=6)for the instrumental precision test and 0.41%(n=6)for the reproducibility test.The mean recovery was 100.6%with an RSD of 0.97%(n=9).Conclusion This method is simple,sensitive,with good separation and accurate results,which can be used as a method for quality control of active pharmaceutical ingredients in raw materials of furagin.
关键词
呋喃烯啶/原料药/高效液相色谱法/质量控制Key words
furagin/raw materials/HPLC/quality control引用本文复制引用
出版年
2024
NETL
NSTL
万方数据