高效液相色谱法测定小儿退热凝胶中对乙酰氨基酚和马来酸氯苯那敏含量  

Determination of Paracetamol and Chlorphenamine Maleate in Xiaoer Tuire Gel by HPLC

作　　者：刘文雅[1] 王争[1] 李黎[1] 

机构地区：[1]中国人民解放军南京军区南京总医院制剂科,江苏南京210002

出　　处：《中国药业》2014年第21期41-42,共2页China Pharmaceuticals

摘　　要：目的建立同时测定小儿退热凝胶中对乙酰氨基酚和马来酸氯苯那敏含量的高效液相色谱（HPLC）法。方法采用HederaODS-2 C18柱（250 mm×4.6 mm,5μm）为色谱柱,以甲醇-0.05 mol/L磷酸二氢钾溶液-三乙胺（10∶90∶0.03,磷酸调p H至3.7）为流动相,检测波长215 nm。结果对乙酰氨基酚进样质量浓度在0.200 6~2.006 4 g/L范围内与峰面积积分值呈良好线性关系（r=0.999 9）,平均回收率为99.47%,RSD=1.08%（n=6）;马来酸氯苯那敏在16.16~161.60μg/m L范围内与峰面积呈良好线性关系（r=0.999 9）,平均回收率为99.03%,RSD=1.45%（n=6）。结论该方法简便、快速、重复性好,两组分分离度好,测定结果准确、可靠,可用于小儿退热凝胶的质量控制。Objective To establish a method for the content determination of paracetamol and chlorphenamine maleate in Xiaoer Tuire Gel by HPLC. Methods The Hedera- ODS- 2 C18 column（ 250 mm × 4. 6 mm, 5 μm） was used. The mobile phases consisted of methanol- 0. 05 mol / L phosphoric acid- triethylamine solution（ 10 ∶ 90 ∶ 0. 03）（ adjusting p H to 3. 7） and the detection wavelength was at 215 nm. Results The linear range of paracetamol was 0. 200 6- 2. 006 4 g / L（ r = 0. 999 9） and the average recovery rate was99. 47% with RSD of 1. 08%（ n = 6）; the linear range of chlorphenamine maleate was 16. 16- 161. 60 μg / m L（ r = 0. 999 9） and the average recovery rate was 99. 03% with RSD of 1. 45%（ n = 6）. Conclusion The established method is simple and rapid with good reproducibility,good separation between the two groups and reliable and accurate detection results,which is suitable to the quality control of Xiaoer Tuire Gel.

关 键 词：小儿退热凝胶 对乙酰氨基酚 马来酸氯苯那敏 高效液相色谱 

分 类 号：R284.1[医药卫生—中药学] R286.0[医药卫生—中医学]