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

关键词:  硫酸阿托品  含量  含量均匀度  高效液相色谱法

Key words:  atropine sulfate  content  content uniformity  HPLC

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，5 μm)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pH值至6.0)-甲醇(75∶25)为流动相，流速：1.0 mL·min^-1，检测波长：210 nm，柱温：35 ℃，进样量：20 μL。结果 硫酸阿托品浓度在5.878 8~58.788 μg·mL^-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。

Abstract:

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 pH 6.0 by phosphoric acid)-methanol(75∶25) at the flow rate of 1.0 mL?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·mL^-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.