摘要
目的:建立了柱前衍生-高效液相色谱荧光法测定硫普罗宁片含量。方法:供试品经 N-(1-芘)马来酰亚胺(NPM)衍生化后,采用 Kromasil C_(18)柱(250 mm×4.6 mm,5 μm),流动相为水(含0.02%磷酸和0.8%冰乙酸)-乙腈(52:48),pH=3.0;流速0.8 mL·min^(-1),在λ_(ex)=330 nm,λ_(em)=380 nm 处荧光检测。结果:硫普罗宁在5.0～50.0μg·mL^(-1)浓度范围内与其衍生化主产物峰面积呈良好的线性关系,r=0.9993,平均回收率为99.5%(RSD=1.0%)。结论:该法准确可靠,专属性强,能满足制剂质量控制的要求。
The method of the RP - HPLC determination of tiopronin in tablets coupling with precolumn derivatization was developed. Methods ： The sample was derivatized with N - （ 1 - pyrenyl） maleimide. The separation was performed on a Kromasil C18 column （250 mm ×4.6mm,5μm）. The mobile phase was composed of water （containing phosphoric acid 0. 02% and glacial acetic acid 0. 8% ） -acetonitrile （52：48）, pH 3.0. The flow rate was 0. 8 mL·min^ -1 and fluorescence detection at λex = 330 nm and λem = 380 nm. Results：A linearity between major derivative peak area and tiopronin concentration was achieved in the range of 5.0 -50. 0 μg·mL^-1, with r = 0. 9993. The average recovery was 99.5% （RSD = 1.0% ）. Conclusion：The method is specific,accurate and convenient,and can be used for quality control of tiopronin tablets.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2008年第8期1336-1338,共3页
Chinese Journal of Pharmaceutical Analysis
