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目的:建立高效液相色谱法测定复方苯妥英钠凝胶剂中苯妥英钠的含量。方法:采用ZORBAX SB-C_(18)色谱柱(250 mmx46 mm,5μm);流动相为0.05 mol·L~(-1)磷酸二氢铵(用磷酸调pH 2.5)-乙腈-甲醇(45:35:20);流速0.8 ml·min~(-1);检测波长220 nm;柱温:25℃。结果:苯妥英钠在18.012-42.028μg·ml~(-1)浓度范围内线性关系良好(r=0.999 0);平均回收率为100.2%(RSD=0.45%,n=9)。结论:本方法简单,灵敏,重复性好,可用于复方苯妥英钠凝胶剂中苯妥英钠的含量测定。
Objective: To establish a method for the determination of phenytoin sodium in compound phenytoin sodium gel by high performance liquid chromatography. METHODS: ZORBAX SB-C 18 column (250 mm × 46 mm, 5 μm) was used. The mobile phase consisted of 0.05 mol·L -1 ammonium dihydrogen phosphate (adjusted to pH 2.5 with phosphoric acid) -acetonitrile- 35:20). The flow rate was 0.8 ml · min -1. The detection wavelength was 220 nm. The column temperature was 25 ℃. Results: Phenytoin had a good linearity (r = 0.999 0) within the range of 18.012-42.028μg · ml -1. The average recovery was 100.2% (RSD = 0.45%, n = 9). Conclusion: The method is simple, sensitive and reproducible. It can be used for the determination of phenytoin sodium in compound phenytoin sodium gel.