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目的:建立测定二氟泼尼酯原料药中有关物质含量的方法。方法:采用反相高效液相色谱法。色谱柱为ShimadzuVP-ODS,流动相为甲醇-水(50∶50),流速为1.0ml/min,检测波长为240nm,进样量为15μl。结果:二氟泼尼酯与相邻峰的分离度为2.50,二氟泼尼酯检测质量浓度线性范围为1.126～9.008mg/m(lr=0.9999),精密度与稳定性试验的RSD分别为0.03%(n=6)、0.11%(n=7),检测限和定量限分别为56.3、281.5ng。3批样品中有关物质含量分别为0.29%、0.23%、0.19%。结论:本方法简便、结果准确,可用于二氟泼尼酯原料药中有关物质的测定。
Objective: To establish a method for the determination of related substances in difluprednate drug substance. Methods: Reversed-phase high performance liquid chromatography. The column was Shimadzu VP-ODS. The mobile phase was methanol-water (50:50), the flow rate was 1.0 ml / min, the detection wavelength was 240 nm and the injection volume was 15μl. Results: The separation of difluprednate from adjacent peaks was 2.50 and the linear range of difluprednate was 1.126-9.008 mg / m (lr = 0.9999). The RSDs of precision and stability were 0.03% (n = 6), 0.11% (n = 7). The limits of detection and quantification were 56.3,281.5ng. Three batches of samples related substances were 0.29%, 0.23%, 0.19%. Conclusion: The method is simple and accurate and can be used for the determination of related substances in difluprednate drug substance.