维生素KD钙片中维生素K2的测定研究和认证

Determination and Certification of Vitamin K2 in Vitamin KD Calcium Tablets

本文建立了快速测定维生素KD钙片中维生素K2的测试方法。采用Thermo公司的Thermo Ultimate 3000型液相色谱仪系统,Agilent Zorbax SB-C18 150 mm×4.6 mm×5μm分析柱,北京普析通用/TU-109紫外检测器,异丙醇∶甲醇(1∶4,v/v)为流动项,流速:1.2 mL·min^-1,进样量:5μL,柱温:30℃,检测波长:248 nm。结果表明,维生素K2的实际回收率和基质回收变异系数均符合规定要求,说明该方法快速、简便、准确、灵敏度高,适合维生素KD钙片中维生素K_2的定量研究。

A rapid method for the determination of vitamin K2 in vitamin KD calcium tablets was established.The thermo ultimate 3000 liquid chromatograph system of thermo company was used.The analytical column was Agilent Zorbax sb-C18150 mm×4.6 mm×5μm.The UV detector was universal/TU-109.The mobile phase was isopropanol∶methanol(1∶4,v/v).The flow rate was 1.2 mL·min^-1,the injection volume was 5μL,the column temperature was 30℃,and the detection wavelength was 248 nm.The results showed that the actual recovery rate and the coefficient of variation of matrix recovery of vitamin K2 met the requirements of the regulation,indicating that the method was rapid,simple,accurate and sensitive,and suitable for the quantitative study of vitamin K2 in vitamin KD calcium tablets.