RP-HPLC检测注射用脂溶性维生素(Ⅱ)中间品含量

Content determination of the mid-profection of fat soluble vitamins (Ⅱ) for Injection by RP-HPLC

目的:建立注射用脂溶性维生素(Ⅱ)中间品含量快速高效液相检测方法。方法:采用SemmetryRP-C18色谱柱(4.6mm×150mm,5μm),流动相:甲醇-水(梯度洗脱),流速:1.5ml/min,检测波长:265nm。结果:维生素A棕榈酸酯、维生素K1、维生素D2及维生素E浓度分别在0.144～0.216μg、0.240～0.360μg、8.000～12.000ng、14.560～21.840μg内呈良好的线性关系;平均回收率分别为99.74%(RSD=0.08%),98.49%(RSD=0.23%),99.83%(RSD=0.22%),99.30%(RSD=0.23%)。结论:该方法简便、快捷、灵敏,能有效控制产品质量。

Objective：To establish a method for the content determination of the mid-profection of fat soluble vitamins （Ⅱ） for Injection by RP-HPLC. Methods：Semmetry RP-C18 column （4.6 mm×150 mm,5 μm） was used. The mobile phases consisted of methanol and water （gradient elution）,the flow rate was 1.5 ml/min and the detection wavelength was at 265 nm. Results：The method was proved to be linear when concentrations of vitamin A,K1,D2 and E were in the range of 0.144-0.216 μg,0.240-0.360 μg,8.000-12.000 ng,14.560-21.840 μg,respectively. The average recoveries and relative standard deviations of vitamin A,K1,D2 and E were 99.74% （RSD=0.08%）,98.49% （RSD=0.23%）,99.83% （RSD=0.22%）and 99.30% （RSD=0.23%）,respectively. Conclusion：The method is simple,rapid,accurate and can be used for the quality control of the fat soluble vitamins for injection （Ⅱ）.