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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(150mm×4.6mm,5μm)色谱柱,以甲醇-乙腈-乙醇-水(20∶55∶25∶6)为流动相,流速1.5mL·min-1,检测波长265nm。结果维生素A棕榈酸酯、维生素D2、E、K1进样量分别在1.19~2.78μg、6.14~14.33ng、10.92~25.48μg、0.19~0.44μg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。
Objective To establish a method for simultaneous determination of vitamin A palmitate, vitamin D2, E and K1 in fat-soluble vitamin for injection by HPLC. Methods The mobile phase consisted of methanol-acetonitrile-ethanol-water (20:55:25:6) with a flow rate of 1.5 mL · min-1 on an Intersil (ODS-2) C18 column (150 mm × 4.6 mm, Wavelength 265nm. Results The injection volumes of vitamin A palmitate, vitamin D2, E and K1 showed a good linearity in the range of 1.19-2.88μg, 6.14-14.33ng, 10.92-25.48μg and 0.19-0.44μg, respectively. The average recoveries were 99.70 % (RSD = 0.48%), 100.13% (RSD = 0.88%), 99.74% (RSD = 0.69%), 99.97% (RSD = 0.59%). Conclusion The method is simple, accurate, reliable and can control the quality of fat-soluble vitamins for injection.