马来酸氯苯那敏片溶出度检查方法的改进  

Dissolution Determination of Chlorphenamine Maleate Tablets

作　　者：杨静[1] 尹娜娜[2] 苗爱东[1] 

机构地区：[1]北京军区联勤部药品仪器检验所生测室,北京100071 [2]河北北方学院,河北张家口075000

出　　处：《解放军药学学报》2015年第6期518-520,共3页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的研究改进马来酸氯苯那敏片的溶出度检查方法。方法采用水900 ml为溶出介质,50 r·min^(-1),15min取样;Agilent ZORBAX SB-C18(4.6 mm×150 mm)色谱柱,0.5%三乙胺溶液(磷酸调节pH 4.0)-乙腈-甲醇(68∶23.8∶8.2)为流动相,流速1.0 ml·min^(-1),柱温:40℃,检测波长262 nm。结果马来酸氯苯那敏浓度在1.0952~10.9520μg·ml^(-1)范围内与峰面积呈良好的线性关系,回归方程为Y=57.872 X-27.957(r=0.9996,n=6),平均回收率为101.10%,RSD=1.56%,n=9。按照《医疗用药品品质情报集》限度为15 min溶出标示量的80%为标准,样品的不合格率为33.33%。结论改进的方法简便易行,准确度高,重复性好,可用于该制剂的质量控制。Objective To establish a novel method for dissolution determination of chlorphenamine maleate tablets. Methods The dissolution rate was determined by HPLC with 900 ml water as the dissolution medium and at a rotation speed of 50 r·min^-1. The Agilent ZORBAX SB-C18（ 4. 6 mm × 150 mm） was used with 0. 5% three aqueous solution（ p H 4. 0 adjusted with phosphoric acid）- acetonitrile-methanol（ 68∶ 23. 8∶ 8. 2） as the mobile phase at40 ℃. The detection wavelength was 262 nm and the flow rate was 1. 0 ml·min^-1. Results The caliblation curve was linear within the range of 1. 0952-10. 9520 μg·ml^-1（ r = 0. 9996,n = 6）. The average recovery was101. 10%（ RSD = 1. 56%,n = 9）. The unqualified rate of 6 batches of samples was 33. 33%. Conclusion This method is simple,accurate and reproducible. It can be used for quality control of this preparation.

关 键 词：马来酸氯苯那敏片 溶出度 HPLC 

分 类 号：R917[医药卫生—药物分析学]