氨酚伪麻那敏分散片溶出度检查方法的建立  

Establishment of the Dissolution Test of Paracetamol,Pseudoephedrine Hydrochloride and Chlorphenamine Maleate Dispersible Tablets

作　　者：吴晓冬 杨翠平[3] 彭维[3] 

机构地区：[1]深圳市药品检验研究院,广东深圳518057 [2]深圳药品质量标准研究重点实验室,广东深圳518057 [3]中山大学生命科学学院,广东广州510275

出　　处：《今日药学》2017年第12期822-825,共4页Pharmacy Today

摘　　要：目的建立测定氨酚伪麻那敏分散片中对乙酰氨基酚、盐酸伪麻黄碱及马来酸氯苯那敏溶出度的方法。方法色谱柱为Agilent HC-C_(18)柱(4.6 mm×250 mm,5μm),测定对乙酰氨基酚的流动相为甲醇-0.05 mol·L^(-1)-磷酸二氢钾溶液-三乙胺(20∶80∶0.02,V/V);检测波长为244 nm;测定盐酸伪麻黄碱与马来酸氯苯那敏的流动相为乙腈-0.5%十二烷基磺酸钠溶液-三乙胺(57∶43∶0.06,V/V)(磷酸调至pH 4.0);检测波长为260 nm。结果对乙酰氨基酚、盐酸伪麻黄碱及马来酸氯苯那敏分别在4~820μg·mL^(-1)、3~466μg·mL^(-1)和0.2~62μg·mL^(-1)的浓度范围内线性良好。3个主药成分的回收率均良好。来自两个厂家的5批样品在溶出15 min取样检测时溶出度均在85%以上。结论建立的方法专属性强,可用于氨酚伪麻那敏分散片中3个有效成分溶出度的质量控制。OBJECTIVE To establish a method for the dissolution determination of paracetamol,pseudoephedrine hydrochloride and chlorphenamine maleate dispersible tablets. METHODS HPLC was performed on the column of Agilent HC-CIS（ 4.6 mmx250 ram,5 μm）. The mobile phase for paracetamol was methanol-0.05 mol. L-1 Potassium dihydrogen phosphate - triethylamine （20：80： 0.02,V/V） ,and the wavelength was 244 nm. The mobile phase for pseudoephedrine hydrochloride and chlorphenamine maleate was 0.5% acetonitrile-dodecyl sulfonate sodium - triethylamine（57 ：43 ：0.06, V/V） （phosphoric acid adjusted to pH 4.0）, and the wavelength was 260 nm. RESULTS The linear ranges were 4-820 μg.mL-1,3-466 μg.mL-I and 0.2-62 μg. mL^-1 for paracetamol, pseudoephedrine hydrochloride and chlorphenamine maleate, respectively. All the results of average recoveries were satisfactory. The dissolution rate of five batches of samples at 15 minutes were all above 85%. CONCLUSION The method is specific and can be used for the dissolution determination of oaracetamol.oseudoeDhedrine hvdrochloride and chlomhenamine maleate disnersihle tablets_

关 键 词：氨酚伪麻那敏分散片 溶出度 高效液相色谱 

分 类 号：R927.2[医药卫生—药学]