复方氨酚苯海拉明片中盐酸苯海拉明及盐酸麻黄碱含量均匀度考察  

Study on the content uniformity of diphenhydramine hydrochloride and ephedrine hydrochloride in compound paracetamol and diphenhydramine hydrochloride tablets

作　　者：李会轻 赵宗阁[2] 王尊文 栾成章 

机构地区：[1]青岛市药品检验所,青岛266071 [2]中国药品生物制品检定所,北京100050

出　　处：《药物分析杂志》2010年第2期349-351,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:测定复方氨酚苯海拉明片中盐酸苯海拉明及盐酸麻黄碱含量均匀度。方法:采用HPLC法,色谱柱:迪马Kroma-silC18(250mm×4.6mm,5μm),流动相:乙腈(A)-水(磷酸调节pH至2.1)(B),梯度洗脱[0min(12%A)→6min(12%A)→14min(50%A)→15min(12%A)→22min(12%A)];流速:1.0mL.min-1;柱温:30℃;检测波长:215nm。结果:所测定的7批样品中,除有3批样品含量均匀度为A+1.80S<15.0,其余含量均匀度为A+1.80S>15.0,有显著性差异(p<0.01)。结论:本法可用于该制剂的含量均匀度检查。Objective：To determine the content uniformity of diphenhydramine hydrochloride and ephedrine hydrochloride in compound paracetamol and diphenhydramine hydrochloride tablets.Methods：HPLC methods were adopted,the chromatographic C18 column（250 mm×4.6 mm,5 μm） was used.The mobile phase consisted of acetonirrile（A）-water（adjusted to pH 2.1 with phosphoric acid）（B） with gradient elution／[0 min（12% A）→6 min（12% A） →14 min（50% A） →15 min（12% A） →22 min（12%A）／] and the flow rate was 1.0 mL/min-1.The detection wavelength was 215 nm.Results：The results showed that the content uniformity of 3 batches were A＋1.80 S〈15.0,the content uniformity of other 4 batches were A＋1.80 S〉15.0,showed markedly difference（p〈0.01）.Conclusion：It can be used to determine the content uniformity of compound paracetamol and diphenhydramine hydrochloride tablets.

关 键 词：复方氨酚苯海拉明片 含量均匀度 盐酸苯海拉明 盐酸麻黄碱 

分 类 号：R917[医药卫生—药物分析学]