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目的:建立测定地夫可特含量及有关物质的高效液相色谱方法。方法:采用VP-ODS色谱柱(250 mm×4.6 mm,5μm),以水-乙腈(60∶40)为流动相,流速1.0 mL.min-1,检测波长244 nm。结果:在上述色谱条件下,各中间体及降解产物均可与地夫可特主峰良好分离。地夫可特与有关物质测定的线性范围分别为50.2～201.0“g.mL-1(r=0.9999)与2.0～15.1”g.mL-1(r=0.9993);方法的重复性与中间精密度RSD分别为0.43%和0.68%。结论:本文方法简便,可用于测定地夫可特的含量及有关物质。
Objective: To establish a HPLC method for determination of deflazac and its related substances. METHODS: VP-ODS column (250 mm × 4.6 mm, 5 μm) was used with a mobile phase of water-acetonitrile (60:40) at a flow rate of 1.0 mL · min-1 and a detection wavelength of 244 nm. Results: Under the above chromatographic conditions, all intermediates and degradation products were well separated from deflazacortone. The linear range of delfac and related substances were 50.2 ~ 201.0 “g.mL-1 (r = 0.9999) and 2.0-15.1” g.mL-1 (r = 0.9993) The intermediate precision RSD was 0.43% and 0.68%, respectively. Conclusion: This method is simple and can be used to determine the content and related substances of deflakt.