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目的:建立RP-HPLC测定醋酸氟轻松的有关物质和含量。方法:色谱柱:Sepax Sapphire C18(4.6mm×250mm,5μm),流动相:甲醇-乙腈-水(60∶10∶30),流速:1.0mL·min-1,检测波长:240nm,进样量:20μL。结果:醋酸氟轻松有关物质线性范围为0.0693～4.156μg·mL-1(r=0.9992),杂质限度范围为0.05%～3.0%,最低检测限为0.6ng(0.02%);含量测定线性范围为5.05～50.5μg·mL-1(r=0.9999)。结论:本方法准确、简便、快速,可满足醋酸氟轻松的有关物质和含量的测定。
Objective: To establish a RP-HPLC determination of related substances and content of fluocinolone acetonide. Method: Column: Sepax Sapphire C18 (4.6mm × 250mm, 5μm), mobile phase: methanol-acetonitrile-water (60:10:30), flow rate 1.0mL · min -1, detection wavelength 240nm, : 20 μL. Results: The linear ranges of fluocinonide-related substances ranged from 0.0693 to 4.156 μg · mL-1 (r = 0.9992), with the limits of impurities ranging from 0.05% to 3.0% and the lowest detection limits of 0.6 ng (0.02%). The linear range 5.05 ~ 50.5μg · mL-1 (r = 0.9999). Conclusion: This method is accurate, simple and rapid, and can meet the determination of related substances and contents of fluocinonide acetate.