RP-HPLC测定自乳化释药系统中伊曲康唑的含量___

Abstract Objective: To establish a RP-HPLC method for determining the content of itraconazole self-emulsifying drug delivery system. Methods: HPLC analysis was performed on a Diamonsil C₁₈  column (4.6 mm×200 mm, 5 μm）with mobile phase of methanol-water (90:10). The flow rate was 1.0 mL·min^-1. The UV detector wavelength was set at 261 nm .The column compartment temperature was set at 25 ℃. The injection volume was 20 μL. Results: Itraconazole had a good linear relation in the range of 1.0-50.0 μg · mL^–1 (r=0.9999). The precisions (RSD) was 0.7%-3.2% (n = 5), the reproducibility (RSD) was 2.9% (n = 5), the average recovery rate was 101.9 % (n = 5). Conclusion: The developed method is simple, accurate and reliable for determination of the content of itraconazole in self-emulsifying drug delivery system.