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目的:建立HPLC测定醋酸地塞米松乳膏中维生素E含量的方法,并用于醋酸地塞米松乳膏中维生素E含量的测定。方法:采用Inertsil ODS-SP色谱柱(4.6 mm×150 mm,5μm);流动相甲醇-水(98∶2),检测波长284 nm;柱温40℃,流速为1 mL·min-1。结果:维生素E在0.029 6~0.296 mg·L-1具有良好的线性关系(r=0.999 9),平均回收率为99.70%~101.80%,RSD为0.9%。结论:经方法学验证后,确定本方法准确度高,重复性好,可作为醋酸地塞米松乳膏中维生素E的含量测定方法。
OBJECTIVE: To establish a method for the determination of vitamin E in dexamethasone acetate cream by HPLC and to determine the content of vitamin E in dexamethasone acetate cream. METHODS: Inertsil ODS-SP column (4.6 mm × 150 mm, 5 μm) was used. The mobile phase was methanol-water (98: 2) and the detection wavelength was 284 nm. The column temperature was 40 ℃ and the flow rate was 1 mL · min-1. Results: Vitamin E had a good linearity (r = 0.999 9) between 0.029 6 and 0.296 mg · L -1, with an average recovery of 99.70% -101.80% and a RSD of 0.9%. Conclusion: The method is validated by the method to determine the accuracy of this method, good repeatability, can be used as a method for determination of Vitamin E in dexamethasone acetate cream.