摘要:
目的: 建立HPLC同时测定复方苯硝那敏片中维生素B6、苯巴比妥、马来酸氯苯那敏和硝西泮含量的方法。 方法: 色谱柱用十八烷基硅烷键合硅胶为固定相（150 mm×4.6 mm,4.6μm）。流动相A:乙腈-水-三乙胺（100:900:1,含0.01 mol/L庚烷磺酸钠,用冰醋酸调pH值3.5）,流动相B:乙腈。洗脱程序:0～12 min,A 100%～70%;12～200 min,A 70%;流速:1 mL/min,检测波长260 nm。 结果: 维生素B6、苯巴比妥、马来酸氯苯那敏和硝西泮的保留时间分别约为4.6、10.2、12.3和14.3 min,与各自相邻峰的分离度均大于1.5。以峰面积对进样量（μg）线性回归,维生素B6回归方程:y=251.4x+2.403,线性范围:0.1684～2.021μg,r=0.9998;苯巴比妥回归方程:y=145.8x+1.612,线性范围:0.5108～6.130μg,r=0.999 9;马来酸氯苯那敏回归方程:y= 697.3x-7.252,线性范围:0.122 8～1.474μg,r=0.999 9;硝西泮回归方程:y=2767x+17.75,线性范围:0.04960～0.595 2μg,r=0.9998。维生素B6、苯巴比妥、马来酸氯苯那敏和硝西泮回收率分别为100.1%、99.4%、99.3%和100.7%,RSD分别为0.18%、0.13%、0.47%和0.16%。 结论: 本方法精密度、准确度好,操作简便,可用于复方苯硝那敏片中维生素B6、苯巴比妥、马来酸氯苯那敏和硝西泮含量测定。
Abstract:
Objective: To develop an HPLC quantitative method for the determination of vitaminB6,phenobarbital,chlorphena- mine maleate and diazepam in compound benxiaonamin tablets. Methods: The chromatographic conditions include column C18 （150 mm×4.6 mm,4.6μm）;mobile phase A:aeetonitrile-water-triethylamine（100:900:1,contain 0.01 mol/L Sodium Heptane, adjusted to pH 3.5 by acetic aeid）;mobile phase B:aeetonitrile,gradient elution:0～12 min,A:100%～70%,12～20 min,A: 70%.The flow rate was 1 mL/min and monitored at 260 nm. Results: The retention time of vitaminB6,phenobarbilal,chlorphena- mine maleate and diazepam were 4.6 min,10.2 min,12.3 min and 14.3 min respectively.The regress equation for VitaminB6 was y=251.4x+2.403,r=0.999 8,and the linear range was0.1684～2.021μg,phenobarbital y=145.8x+1.612,r=0.9999 and the linear range was 0.510 8～6.130μg;ehlorphenamine maleate y=697.3x-7.252,r=0.999 9,and the linear range was 0.122 8～1.474μg,diazepam y=2767x+17.75,r=0.999 8 and the linear range was 0.049 60～0.595 2μg.The average re- covery of vitaminB6,phenobarbital,chlorphenamine maleate and diazepam were 100.1%,99.4%,99.3% and 100.7%;and RSD were 0.18%,0.13%,0.47% and 0.16% respectively. Conclusion:: The method was sensiteve,time-saving and accurate.
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