高效液相色谱法测定抗放利含量

摘要

Objective To determine the content of 2,2-dimethylthiazolidine hydrochloride (KFL)by HPLC. Methods The sample was separated on SunFireTM C18 (250 mm × 4.6 mm,5 μm)with mobile phase consisted of methanol-50 mmol/L ammonium acetate peroxide solution (40:60) at a flow rate of 1.0 ml/min. The detection wavelength was 220 nm. Results The linear range of KFL was 0.216-2.376 mg/ml(r=0.999 9) with an average recovery of 98.8% (RSD 为 1.4%,n=9). Conclusion The method developed is accurate,stable and reproducible,so it may be used in the content determination and provides basis for the improvement of the quality standard of KFL and its pharmaceutical preparation.%目的 建立以高效液相色谱法测定2,2-二甲基四氢噻唑盐酸盐(抗放利)含量的方法.方法 色谱柱为SunFireTM C18(250 mm×4.6 mm,5μm),流动相为甲醇-50 mmol/L醋酸铵水溶液(40:60),流速为1.0 ml/min,检测波长为220 nm.结果 抗放利在0.216～2.376 mg/ml范围内与峰面积积分值呈良好的线性关系(r=0.999 9)；平均回收率为98.8%,RSD为1.4%(n=9).结论 本方法准确、稳定、重现性好,可用于抗放利的含量测定,并为完善抗放利及其制剂的质量标准提供依据.