HPLC测定硫酸阿托品片的含量及含量均匀度  

Determination of the Content and Content Uniformity of Atropine Sulfate Tablets by HPLC

作　　者：陈德俊 徐志洲 张雷 刘明洁 

机构地区：[1]山东省食品药品检验研究院,济南250101

出　　处：《中国现代应用药学》2015年第7期853-855,共3页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的建立高效液相色谱法测定硫酸阿托品片的含量及含量均匀度。方法采用SHISEIDO CAPCELL C18（250 mm×4.6 mm,5μm）色谱柱,以0.01 mol·L-1磷酸二氢钾溶液（含0.15%三乙胺,用磷酸调节p H值至6.0）-甲醇（75∶25）为流动相,流速：1.0 m L·min-1,检测波长：210 nm,柱温：35℃,进样量：20μL。结果硫酸阿托品浓度在5.878 8~58.788μg·m L-1内线性关系良好,回归方程为Y=24.015 8X＋0.095 9,r=1.000 0,平均回收率为100.2%（n=9）。结论该方法简便快速,可用于硫酸阿托品片含量和含量均匀度的测定。OBJECTIVE To establish an HPLC method for the determination of the content and content uniformity of atropine sulfate tablets. METHODS SHISEIDO CAPCELL C18 chromatographic column（250 mm×4.6 mm, 5 μm） was adopted. The mobile phase was 0.01 mol·L-1 potassium dihydrogen phosphate solution（including 0.15% triethylamine, adjusted to p H 6.0 by phosphoric acid）-methanol（75∶25） at the flow rate of 1.0 m L·min-1. The detection wavelength was 210 nm, and the column temperature was 35 ℃. The injection volume was 20 μL. RESULTS Good linear correlation was found in the range of 5.878 8-58.788 μg·m L-1, and the linear equation was Y=24.015 8X＋0.095 9, r=1.000 0. The average recovery was 100.2%（n=9）. CONCLUSION This method is simple, rapid and efficient for the quality control of atropine sulfate tablets.

关 键 词：硫酸阿托品 含量 含量均匀度 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]