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目的:建立GC法测定复方醋酸氟轻松酊中二甲亚砜、间苯二酚、冰片和甘油的含量。方法:色谱柱:HP-INNOWax(30.0 m×0.32 mm,0.25μm);进样口温度:280℃;检测器温度:290℃;分流比:10∶1;以氮气为载气,流速:2.0 ml·min~(-1);程序升温:初始温度100℃,保持5 min,以20℃·min~(-1)的速率升温至240℃,保持8 min;氢气流量:35 ml·min~(-1);空气流量:350 ml·min~(-1);尾吹气流量:25 ml·min~(-1);以奈为内标。结果:二甲亚砜、间苯二酚、冰片和甘油的浓度分别在99.20~793.60μg·ml~(-1)(r=0.999 9)、507.25~4 058.00μg·ml~(-1)(r=0.999 9)、102.20~817.60μg·ml~(-1)(r=1.000 0)、316.20~2 529.60μg·ml~(-1)(r=1.000 0)范围内线性关系良好,平均回收率分别为98.58%、98.34%、98.19%、102.29%,RSD分别为3.80%、3.93%、2.87%、3.65%(n=9)。结论:该方法简便、准确、可靠,可用于复方醋酸氟轻松酊中二甲亚砜、间苯二酚、冰片和甘油的质量控制。
OBJECTIVE: To establish a method for the determination of dimethyl sulfoxide, resorcinol, borneol and glycerol in compound fluocinolone acetonide. Method: Column: HP-INNOWax (30.0 m × 0.32 mm, 0.25 μm); Inlet temperature: 280 ℃; Detector temperature: 290 ℃; Split ratio: 10: 1; Nitrogen as carrier gas; ml · min ~ (-1). The temperature was raised to 100 ℃ for 5 min and the temperature was increased to 240 ℃ at 20 ℃ · min ~ (-1) for 8 min. The hydrogen flow rate was 35 ml · min ~ (-1); air flow rate: 350 ml · min ~ (-1); makeup air flow rate: 25 ml · min ~ (-1); Results: The concentrations of dimethyl sulfoxide, resorcinol, borneol and glycerol were 99.20 ~ 793.60μg · ml ~ (-1) (r = 0.999 9), 507.25 ~ 4 058.00μg · ml ~ (-1) Linear correlation was good in the range of 102.20-817.60μg · ml -1 (r = 1.000 0) and 316.20-2 529.60μg · ml -1 (r = 1.000 0) The rates were 98.58%, 98.34%, 98.19% and 102.29%, respectively. The RSDs were 3.80%, 3.93%, 2.87% and 3.65%, respectively (n = 9). Conclusion: The method is simple, accurate and reliable and can be used for the quality control of dimethyl sulfoxide, resorcinol, borneol and glycerol in the compound fluocinolone acetonide tincture.