Determination of atropine sulfate injection by high performance liquid chromatography
HUANG Xiaojiang1， XIAO Zhixin1， ZHU Fengxiao1， WANG Yifang1， ZHU Ting2， QIN Jubo2， LIU Mingxing1
(1.School ofLife and Health Science， Hubei University of Technology， Wuhan 430068， China；2.Preparation Company of Grand Pharmaceutical (China) Co.， Ltd.， Wuhan 430040， China)
Abstract：In this study， a high-performance liquid chromatography (HPLC) method was established for the determination of atropine sulfate Injection content and its methodological validation. The chromatographic column used was SHISEIDO CAPCELL PAK C18 (4.6 mm × 250 mm， 5 μm). The buffer solution consists of 0.013 mol·L－1 potassium dihydrogen phosphate and 0.014 mol·L－1 pentane sulfonic acid sodium (1.8 g potassium dihydrogen phosphate and 2.5 g pentane sulfonic acid sodium dissolved in 1 L water； pH adjusted to 2.5 with phosphoric acid). Mobile phase A was acetonitrile-buffer solution (5∶95)， and mobile phase B was acetonitrile-buffer solution (80∶20) ＝ 75∶25. The flow rate was set at 1.0 mL·min－1， with detection wavelength at 210 nm， and column temperature at 30 ℃. Under this method， excipients did not interfere with the determination. atropine sulfate exhibited good linearity in the concentration range of 0.049 9 to 0.149 6 mg·mL－1， with a method linear correlation coefficient of r ＝ 1.000 (n＝5). The recovery rate ranged from 99.6% to 100.0% (RSD＝0.4%， n＝9). This method is simple， sensitive reproducible， and accurate， making it suitable for the determination and quality control of atropine sulfate injection.
2025, Vol. 59 
