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目的采用HPLC同时测定维A酸乳膏中维A酸、山梨酸、2,6-二叔丁基-4-甲基苯酚(BHT)的含量和有关物质。方法采用Century SIL C18色谱柱,流动相为甲醇-乙腈-4%冰乙酸(39∶42∶19),流速1.0 m L·min-1,柱温40℃,检测波长280(山梨酸、BHT)、355 nm(维A酸)。结果维A酸与各杂质间的均分离良好,维A酸4.048~16.192μg·m L-1(r=0.9999)、山梨酸32.154~128.614μg·m L-1(r=0.9998)、BHT 12.752~51.008μg·m L-1(r=0.9999)与峰面积的线性关系良好,平均回收率分别为99.46%、99.99%、100.24%(n=9),RSD分别为1.07%、1.05%、0.76%;维A酸的最低检测限(S/N=3)为2.9 ng。结论所用方法简便、准确,可用于维A酸乳膏的质量控制。
OBJECTIVE To determine the contents of retinoic acid, sorbic acid, 2,6-di-tert-butyl-4-methylphenol (BHT) and related substances in Vitamin A acid cream by HPLC simultaneously. The method was based on a Century SIL C18 column with a mobile phase of methanol-acetonitrile-4% glacial acetic acid (39:42:19) at a flow rate of 1.0 mL · min -1. The column temperature was 40 ℃ and the detection wavelength was 280 (sorbic acid, BHT) , 355 nm (retinoic acid). Results The results showed that the ratio of retinoic acid to each impurity was well separated, and the contents of tretinoin in the range of 4.048-16.192 μg · mL -1 (r = 0.9999), sorbic acid 32.154 ~ 128.614 μg · mL -1 (r = 0.9998), BHT 12.752 ~ 51.008μg · m L -1 (r = 0.9999), the average recoveries were 99.46%, 99.99% and 100.24% respectively (n = 9) .The RSDs were 1.07%, 1.05% and 0.76 %; The minimum detectable limit of retinoic acid (S / N = 3) was 2.9 ng. Conclusion The method is simple and accurate and can be used for the quality control of Vitamin A acid cream.