高效液相色谱法测定多组分配方含维生素K2制剂中七烯甲萘醌的含量

Determination of menaquinone-7 in multi-component formulation containing vitamin K2 by high performance liquid chromatography

中文关键词:  维生素K2  七烯甲萘醌  多组分配方制剂  高效液相色谱法

英文关键词:vitamin K2  menaquinone-7  multicomponent formulation  high performance liquid chromatography  

中文摘要:

      目的 建立高效液相色谱法(high performance liquid chromatography, HPLC)测定多组分配方含维生素K2制剂中七烯甲萘醌含量的方法。方法 试样在酸化、酶解后, 经异丙醇提取, 采用反相色谱柱分离, 紫外检测, 外标法定量测定七烯甲萘醌含量。结果 在优化的实验条件下, 七烯甲萘醌在0.20~7.90 μg/mL范围内线性关系良好(r2>0.9995), 方法的定量限为1.6 μg/g, 回收率94.55%~101.05%, 相对标准偏差为2.33%(n=3)。结论 该方法灵敏快速准确, 适用于多组分配方制剂中七烯甲萘醌的含量检测。

英文摘要:

      Objective To establish a method for the determination of menaquinone-7 in multi-component formulation containing vitamin K2 by high performance liquid chromatography. Methods The samples were acidifiied, digested?by?pepsin, and then extracted by isopropyl alcohol. Menaquinone-7 was separated on reversed- phase?chromatographic?column, detected by ultraviolet detection and the content was quantified by the external standard method. Results Under the optimized condition, the linear relationship was good in the range of 0.207.90 μg/mL (r2>0.9995). The limit of quantitation(LOQ) of the method was 1.6 μg/g., the recoveries were in the range of 94.55%101.05% and the relative standard deviation(RSD) was 2.33%(n=3). Conclusion The method is accurate and reliable, and is suitable for the determination of menaquinone-7 in multicomponent formulation.