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目的:建立自乳化释药系统中伊曲康唑含量测定的RP-HPLC法。方法:采用Diamonsil C18(4.6mm×200mm,5μm)色谱柱,流动相为甲醇-水(90∶10),流速1.0mL·min-1,检测波长261nm,柱温25℃,进样量20μL。结果:在本色谱条件下伊曲康唑与辅料及溶剂峰分离良好,伊曲康唑在1.0～50.0μg·mL-1质量浓度范围内与峰面积呈良好的线性关系(r=0.9999),精密度试验的RSD为0.7%～3.2%(n=5),重复性试验的RSD为2.9%(n=5),平均回收率为101.9%(n=5)。结论:该方法简便、易行,可用于自乳化释药系统中伊曲康唑的含量测定。
Objective: To establish a RP-HPLC method for the determination of itraconazole in self-emulsifying drug delivery system. Methods: Diamonsil C18 (4.6mm × 200mm, 5μm) column was used. The mobile phase consisted of methanol-water (90:10), flow rate 1.0mL · min-1, detection wavelength 261nm, column temperature 25 ℃ and injection volume 20μL. Results: Itraconazole was well separated from its excipients and solvent peaks under the chromatographic conditions. Itraconazole had a good linear relationship with the peak area (r = 0.9999) in the range of 1.0 ~ 50.0μg · mL-1, The RSD of the precision test was 0.7% -3.2% (n = 5), and the RSD of the reproducibility test was 2.9% (n = 5). The average recovery was 101.9% (n = 5). Conclusion: This method is simple and easy to perform and can be used for the determination of itraconazole in self-emulsifying drug delivery system.