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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 a HPLC method for the determination of atropine sulfate tablets content and content uniformity. Methods A SHISEIDO CAPCELL C18 (250 mm × 4.6 mm, 5 μm) column was used with 0.01 mol·L-1 potassium dihydrogen phosphate solution containing 0.15% triethylamine and pH adjusted to pH 6.0 with phosphoric acid-methanol (75 : 25) as mobile phase, flow rate: 1.0 m L · min-1, detection wavelength: 210 nm, column temperature: 35 ℃ and injection volume: 20 μL. Results The linear range of atropine sulfate was 5.878 8-58.788 μg · m L-1. The regression equation was Y = 24.015 8X + 0.095 9, r = 1.000 0, with an average recovery of 100.2% (n = 9). Conclusion The method is simple and rapid and can be used for the determination of content and content uniformity of atropine sulfate tablets.