| 引用本文: | 陈德俊,徐志洲,张雷,刘明洁.HPLC测定硫酸阿托品片的含量及含量均匀度[J].中国现代应用药学,2015,32(7):853-855. |
| CHEN Dejun,XU Zhizhou,ZHANG Lei,LIU Mingjie.Determination of the Content and Content Uniformity of Atropine Sulfate Tablets by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2015,32(7):853-855. |
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| 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。 |
| 关键词: 硫酸阿托品 含量 含量均匀度 高效液相色谱法 |
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| Determination of the Content and Content Uniformity of Atropine Sulfate Tablets by HPLC |
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CHEN Dejun, XU Zhizhou, ZHANG Lei, LIU Mingjie
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Shandong Institute for Food and Drug Control, Jinan 250101, China
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| 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. |
| Key words: atropine sulfate content content uniformity HPLC |
