高效液相色谱法测定复方锌布颗粒中马来酸氯苯那敏含量  

Determination of Chlorphenamine Maleate Content in Compound Zinc Gluconate and Ibuprofen Granules by HPLC

作　　者：黄玉昌 曾庆伟 吴芳花 邝美婷 

机构地区：[1]广东省河源市食品药品检验所,广东河源517000 [2]广东医学院,广东东莞523808

出　　处：《中国药业》2014年第1期31-33,共3页China Pharmaceuticals

摘　　要：目的建立测定复方锌布颗粒中马来酸氯苯那敏含量的高效液相色谱法。方法采用十八烷基硅烷建合硅胶柱（250mm×4．6mm．5μm），以磷酸盐缓冲液（取磷酸二氢铵11．5g，加水适量使溶解，加磷酸1mL，用水稀释至1000mL）-乙腈（80：20）为流动相，流速为1．0mL／min，柱温为40℃，检测波长为262nm。结果马来酸氯苯那敏质量浓度在0．008415～0．8415g／L（r=1．0000）范围内与峰面积呈良好线性关系，平均回收率为100．19％（n=9），RSD为0．55％。结论所用方法测定复方锌布颗粒中马来酸氯苯那敏的含量准确，有效，快速，简便，可用于该制剂的质量控制。Objective To establish a high performance liquid chromatography（HPLC） method for the determination of chlorphenamine maleate in Compound Zinc Gluconate and Ibuprofen Granules. Methods The octadecyl silane bonded silica column was adopted（Intersil ODS -SP, 250 mm ~4. 6 mm, 5 ~xm C/N： 5020 -02746 S/N： OAI92654）, the mobile phase was the phosphate buffer solution （dissolving ammonium dihydrogen phosphate 11.5 g with proper amount of water, adding phosphoric acid 1 mL and diluting to 1 000 mL with water）-acetonitrile （80：20）;the flow rate was 1.0 mL/min; the column temperature was 40~C; the detection wavelength was set at 262 nm. Results The linear range of chlorphenamine maleate was 0. 008 415 - 0. 841 5 g/L（ r = 1. 000 0）. The average recovery rate was 100. 19% （ n = 9）, RSD was 0. 55%. Conclusion The used method is accurate, effective, rapid and simple to determine the chlorphenamine maleate content in Compound Zinc Glueonate and Ibuprofen Granules, and can be used for the quality control of this preparation.

关 键 词：复方锌布颗粒 马来酸氯苯那敏 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学] R971.1