目的 建立测定脂溶性维生素注射液中维生素A棕榈酸酯有关物质的反相高效液相色谱法。方法 Diamond C₁₈色谱柱（250 mm×4.6 mm，5 μm），流动相A为甲醇-异丙醇-水（60∶32∶8），流动相B为甲醇-异丙醇（70∶30），梯度洗脱， 体积流量1.0 mL/min，检测波长324 nm，柱温30 ℃。结果 维生素A棕榈酸酯与维生素D₃、维生素E、维生素K₁及其有关物质分离度好，在质量浓度0.206～5.14 mg/L时，维生素A棕榈酸酯的质量浓度与峰面积线性关系良好，检测限为0.041 mg/L。结论 该方法准确可靠，专属性好，可用于脂溶性维生素注射液中维生素A棕榈酸酯的质量控制。

Abstrsc: Objective To establish an HPLC method for determining the related substances of vitamin A palmitate in fat-soluble vitamin injection. Methods The chromatographic separation was performed on a Diamond C₁₈ column (250 mm × 4.6 mm, 5 μm) with a column temperature at 30 ℃. The mobile phase consisted of methanol-isopropanol-water (60 : 32 : 8) as mobile phase A and methanol-isopropanol (70 : 30) as mobile phase B. The flow rate was 1.0 mL/min. The detection wavelength was at 324 nm. Results Vitamin A palmitate was separated well with vitamin D₃, vitamin E, vitamin K₁ and its related substances. The calibration range was from 0.206 to 5.14 mg/L. The detection limit was 0.041 mg/L. Conclusion The method is accurate and specific, and can be used for the quality control of vitamin A palmitate in fat-soluble vitamin injection.