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目的:为控制复方苯硝那敏片质量,建立高效液相色谱法同时测定复方苯硝那敏片中苯巴比妥、硝西泮、维生素B6及马来酸氯苯那敏的含量。方法:选用C18柱IntersilODS-3(4.6mm×250mm,5μm),甲醇-0.01mol·L-1醋酸铵(含0.1%冰醋酸)梯度洗脱,流速:1mL·min-1,检测波长:254nm;进样量:20μL;柱温:35℃。结果:本方法可同时测定复方苯硝那敏片中上述4种主要成分的含量,对复方苯硝那敏片的质量进行控制。苯巴比妥在0.2983～0.5966mg·mL-1(r=0.9999)、硝西泮在0.02525～0.05050mg·mL-1(r=0.9999)、马来酸氯苯那敏在0.03958～0.07915mg·mL-1(r=0.9999)、维生素B6在0.0996～0.1992mg·mL-1(r=0.9998)范围内,峰面积与其浓度呈良好的线性关系。平均回收率分别为:苯巴比妥99.5%,RSD=0.2%(n=3);硝西泮100.6%,RSD=0.2%(n=3);马来酸氯苯那敏100.0%,RSD=0.19%(n=3);维生素B6100.5%,RSD=0.2%(n=3)。结论:该方法简便、灵敏、准确,适用于复方苯硝那敏片中各主要成分的含量测定及该品种的质量控制。
OBJECTIVE: To establish a HPLC method for simultaneous determination of phenobarbital, nitrobazepam, vitamin B6 and chlorphenamine maleate in compound Benixuanna tablets. Methods: A C18 column was used with a gradient of 1 mL · min-1 at a flow rate of 1 mL · min-1 with a gradient of methanol-0.01 mol·L-1 ammonium acetate (0.1% glacial acetic acid) ; Injection volume: 20μL; column temperature: 35 ℃. Results: The method can simultaneously determine the contents of the above four main components in compound Benifenanamin tablets, and control the quality of the compound Benifanganan tablets. Phenobarbital ranged from 0.2983 to 0.5966 mg · mL -1 (r = 0.9999), nitrazepam ranged from 0.02525 to 0.05050 mg · mL -1 (r = 0.9999), chlorpheniramine maleate ranged from 0.03958 to 0.07915 mg · mL-1 (r = 0.9999), vitamin B6 in the range of 0.0996-0.1992 mg · mL-1 (r = 0.9998), and the peak area showed a good linear relationship with its concentration. The average recoveries were phenobarbital 99.5%, RSD = 0.2% (n = 3), nitrazepam 100.6%, RSD = 0.2% (n = 3), chlorpheniramine maleate 100.0%, RSD = 0.19% (n = 3); vitamin B6100.5%, RSD = 0.2% (n = 3). Conclusion: The method is simple, sensitive and accurate. It is suitable for the determination of the main components in Compound Benixanamin Tablets and the quality control of the varieties.