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目的建立HPLC法测定硫酸阿托品注射液含量的方法。方法采用C18(Alltech,4.6mm×250mm,5μm)色谱柱。流动相:乙腈-水-三乙胺(25:75:0.1,V/V),流速1.0ml/min,紫外检测波长210nm,以非那西丁为内标。结果本法硫酸阿托品注射液在40～200μg/ml范围内线性关系良好(r=0.9978,高、中、低3种浓度回收率分别为101.2%、97.6%和102.3%,日内、日间RSD均<5%)。结论本法操作简单,结果准确可靠,可用于硫酸阿托品注射液的质量控制。
Objective To establish a HPLC method for the determination of atropine sulfate injection. Methods A C18 (Alltech, 4.6 mm × 250 mm, 5 μm) column was used. The mobile phase was acetonitrile-water-triethylamine (25:75: 0.1, V / V), the flow rate was 1.0 ml / min and the UV detection wavelength was 210 nm. Phenacetin was used as internal standard. Results The atropine sulfate injection had good linearity in the range of 40 ~ 200μg / ml (r = 0.9978, the recoveries of high, middle and low concentrations were 101.2%, 97.6% and 102.3% respectively. <5%). Conclusion This method is simple, the results are accurate and reliable, and can be used for the quality control of atropine sulfate injection.