目的 建立測(cè)定脂溶性維生素注射液中維生素A棕櫚酸酯有關(guān)物質(zhì)的反相高效液相色譜法。方法 Diamond C₁₈色譜柱（250 mm×4.6 mm，5 μm），流動(dòng)相A為甲醇-異丙醇-水（60∶32∶8），流動(dòng)相B為甲醇-異丙醇（70∶30），梯度洗脫， 體積流量1.0 mL/min，檢測(cè)波長(zhǎng)324 nm，柱溫30 ℃。結(jié)果 維生素A棕櫚酸酯與維生素D₃、維生素E、維生素K₁及其有關(guān)物質(zhì)分離度好，在質(zhì)量濃度0.206～5.14 mg/L時(shí)，維生素A棕櫚酸酯的質(zhì)量濃度與峰面積線性關(guān)系良好，檢測(cè)限為0.041 mg/L。結(jié)論 該方法準(zhǔn)確可靠，專屬性好，可用于脂溶性維生素注射液中維生素A棕櫚酸酯的質(zhì)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.