HPLC法测定复方降压胶囊中氢氯噻嗪、地巴唑、氯氮(艹卓)和盐酸异丙嗪的含量  

HPLC Determination of Hydrochlorothiazide,Dibazol,Chlordiazepoxide and Promethazine Hydrochloride in Compound Dibazol Capsules

作　　者：陈鼎雄[1] 

机构地区：[1]福建省药品检验所,福州350001

出　　处：《药物分析杂志》2005年第4期442-445,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立离子对高效液相色谱法同时测定复方降压胶囊中氢氯噻嗪、地巴唑、氯氮(艹卓)和盐酸异丙嗪含量。方法:分析柱为 Hypersil C_(18)(4.6mm×250mm,5μm),流动相为乙腈-甲醇-7.2mmol·L^(-1)己烷磺酸钠溶液-冰醋酸-三乙胺(28∶28∶43∶1∶0.01),检测波长为258nm。结果:氢氯噻嗪、地巴唑、氯氮(艹卓)和盐酸异丙嗪的线性范围分别为12.24-122.4μg·mL^(-1)(r=0.9997),40.92-409.2μg·mL^(-1)(r=0.9998),8.12-81.2μg·mL^(-1)(r=0.9999),11.52-115.2μg·mL^(-1)(r=0.9999);平均回收率分别为100.3%(RSD<1.4%),99.0%(RSD<1.3%),98.8%(RSD<1.7%),99.4%(RSD<2.3%)。结论:4种组分分离效果好,其他组分和辅料无干扰,本法简便快速,准确可靠,适于该复方制剂中4种组分的同时测定。Objective:To establish a method for the simultaneous determination of four constituents in compound dibazol capsules:hydrochlorothiazide,dibazol,chlordiazepoxide and promethazine hydrochloride.Method:The anal- ysis was achieved by using Hypersil C_(18) column with acetonitrile-methanol-7.2 mmol·L^(-1) sodium hexanesulfon- ate solution-acetic acid glacial-triethylamine (28:28:43:1:0.01 ) as mobile phase and UV-detector at wave- length 258 nm.Results:A satisfactory separation among four components was obtained.The linear response ranges were:12.24-122.4μg·mL^(-1) for hydrochlorothiazide (r=0.9997),40.92-409.2 μg·mL^(-1) for dibazol (r= 0.9998),8.12-81.2 μg·mL^(-1) for chlordizepoxide (r=0.9999),11.52-115.2 μg·mL^(-1) for promethazine hydrochloride (r=0.9999) respectively.The mean recoveries of hydrochlorothiazide,dibazol,chlordiazepoxide and promethazine hydrochloride were 100.3% (RSD<1.4%),99.0% (RSD<1.3%),98.8% (RSD<1.7%), 99.4% (RSD<2.3%)respectively.Conclusion:This method is simple,quick and the result of determination is precise of accurate.This method is suitable for determination of the four constituents in compound preparation.

关 键 词：复方降压胶囊 盐酸异丙嗪 氢氯噻嗪 地巴唑 氯氮zhuo HPLC法 含量 离子对高效液相色谱法 同时测定 平均回收率 检测波长 线性范围 分离效果 复方制剂 三乙胺 冰醋酸 磺酸钠 流动相 组分 

分 类 号：R972.4[医药卫生—药品] R927.2[医药卫生—药学]