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目的:建立HPLC法同时测定勃氏口服液中咖啡因和苯巴比妥钠含量。方法:采用Water XTerra-MSC_(18)柱色谱柱(150 mm×4.6 mm,5μm);以甲醇-水(32:68)为流动相A,甲醇-水(65:35)为流动相B,梯度洗脱;检测波长:240 nm;流速:1.0 ml·min~(-1);柱温:35℃。结果:咖啡因在9.91～198.12μg·ml~(-1)范围内线性关系良好(r=1.000 0);苯巴比妥钠在20.32～406.40μg·ml~(-1)范围内线性关系良好(r=0.999 5);平均回收率咖啡因为100.5%,RSD=0.35%(n=9),苯巴比妥钠99.8%,RSD=0.35%(n=9)。结论:本方法简便,灵敏,准确,重复性和稳定性好,可用于该制剂的质量控制。
Objective: To establish a HPLC method for simultaneous determination of caffeine and phenobarbital sodium in Burs oral solution. Methods: The mobile phase A was methanol-water (32:68) and methanol-water (65:35) was used as mobile phase B on a Water XTerra-MSC 18 column (150 mm × 4.6 mm, Gradient elution; detection wavelength: 240 nm; flow rate: 1.0 ml · min -1; column temperature: 35 ℃. Results: The linear relationship of caffeine in the range of 9.91 ~ 198.12μg · ml ~ (-1) was good (r = 1.000 0). Phenobarbital sodium had good linearity in the range of 20.32 ~ 406.40μg · ml ~ (-1) (r = 0.999 5). The average recoveries were 100.5% for caffeine, RSD = 0.35% (n = 9), phenobarbital 99.8% and RSD = 0.35% (n = 9). Conclusion: The method is simple, sensitive, accurate, reproducible and stable and can be used for the quality control of the preparation.