HPLC测定注射用脂溶性维生素中4种成分的含量

Determination of Four Compounds in Fat-soluble Vitamin for Injection by HPLC

关键词:  高效液相色谱法  维生素A棕榈酸酯  维生素D2  维生素E  维生素K1

Key words:  HPLC  retinol palmitate  vitamin D2  vitamin E  vitamin K1

摘要:

目的建立高效液相色谱法同时测定注射用脂溶性维生素中维生素A棕榈酸酯、维生素D2、E、K1含量的方法。方法采用Intersil (ODS-2) C18 (150 mm×4.6 mm，5 μm)色谱柱，以甲醇-乙腈-乙醇-水(20∶55∶25∶6)为流动相，流速1.5 mL·min-1，检测波长265 nm。 结果维生素A棕榈酸酯、维生素D2、E、K1进样量分别在1.19～2.78 μg、6.14～14.33 ng、10.92～25.48 μg、0.19～0.44 μg内呈良好的线性关系；平均回收率分别为99.70%(RSD=0.48%)、100.13%(RSD=0.88%)、99.74%(RSD=0.69%)、99.97%( RSD=0.59%)。结论方法操作简便、精确、结果可靠，可控制注射用脂溶性维生素的质量。

Abstract:

OBJECTIVE To establish an HPLC method for simultaneous determination of retinol palmitate，vitamin D2，vitamin E and vitamin K1 in fat-soluble vitamin for injection. METHODS An Intersil (ODS-2) C18 (150 mm×4.6 mm，5 μm) was used as separation column. Methanol- acetonitrile- ethanol-water (17∶58∶25∶5) was used as the mobile phase. Flow rate was 1.5 mL·min -1. The detection wavelength was set at 265 nm. RESULTS The linear ranges for retinol palmitate，vitamin D2, vitamin E and vitamin K1 were 1.19-2.78 μg，6.14-14.33 ng，10.92-25.48 μg，0.19-0.44 μg, and the average recoveries were 99.70% (RSD=0.48%), 100.13% (RSD=0.88%)，99.74% (RSD=0.69%), 99.97% (RSD=0.59%), respectively. CONCLUSION The method is simple，accurate，reliable. It can be used for the quality control of fat-soluble vitamin for injection.