HPLC法测定复方苯硝那敏片中苯巴比妥马来酸氯苯那敏和硝西泮含量  

Determination of Phenobarbital Chlorphenamine Maleate and Diazepam In Compound Benxiaonamin Tablets by HPLC

作　　者：谭生建[1] 刘刚[1] 张捷[1] 刘昌叶[1] 潘敏翔[1] 

机构地区：[1]解放军第306医院药学部,北京100101

出　　处：《解放军药学学报》2007年第5期384-386,共3页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的建立HPLC法同时测定复方苯硝那敏片中苯巴比妥、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填充剂（150mm×4.6mm,4.6μm）。流动相：甲醇-水-三乙胺（480∶520∶5,含0.005mol.L^-1庚烷磺酸钠,用磷酸调pH值3.5）;流速：1ml/min;检测波长260nm。结果以峰面积（X）对进样浓度（Y）线性回归,苯巴比妥回归方程：Y=0.619 3X-0.047 40,线性范围23.48-234.8μg.ml-1;马来酸氯苯那敏回归方程：Y=0.046 05X＋0.110 7,线性范围3.240-32.40μg.ml-1;硝西泮回归方程：Y=0.082 09X-0.006 308,线性范围1.986-19.86μg.ml-1;r均为0.999 9。苯巴比妥、马来酸氯苯那敏、硝西泮回收率分别为98.4%、97.4%和101.3%;RSD分别为0.22%、0.95%和2.0%。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苯巴比妥、马来酸氯苯那敏和硝西泮含量测定。Aim To develop an I-IPLC quantitative method for the determination of Phenobarbital Chlorphenamine Maleate and Diazepam in Compound Benxiaonamin Tablets. Methods Chromatographic conditions included the column C18 （ 150mm×4.6mm, 4.61μm） mobile phase ： methanol-water- triethylamine（48： 52：5 ,contain 0. 005mol ·L^-1 Sodium Heptane , adjusted to pH 3.5 by phosphoric acid）. The flow rete was 1 ml/min and monitored at 260nm. Results The regress equation for Phenobarbital was Y =0.619 3X -0.047 40, r =-0.999 9 and the linear range was 23.48 -234.8μg·ml^-1 ;Chlorphenamine Maleate Y =0.046 05X ＋0.110 7, r =0. 999 9 and the linear range was 3. 240 -32.40μg·ml^-1 ;Diazepam Y =0.082 09X-0.006 308, r =0.999 9 and the linear range was 1.986 - 19. 86μg·ml^-1. The average recovery of Phenobarbital, Chlorphenamine Maleate and Diazepam was 98.4%, 97.4% and 101.3%, RSD 0. 22%, 0. 95% and 2.0% respectively. Conclusion This method was sensitive,time-saving and accurate.

关 键 词：HPLC 复方苯硝那敏片 马来酸氯苯那敏 苯巴比妥 硝西泮 

分 类 号：R927.2[医药卫生—药学]