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目的 :建立法莫替丁咀嚼片含量测定的RP HPLC。方法 :采用ShimpackODS柱 (1 50mm× 6mm ,5μm) ,流动相为 :0 .1 %三乙胺的 0 .1mol·L- 1 乙酸钠溶液 (pH6 .0 0 )∶乙腈 (92∶8) ;流速 1 .0ml·min- 1 ,检测波长 2 66nm。结果 :在选定的色谱条件下 ,法莫替丁与有关物质完全分离 ;制剂中辅料对主药无干扰 ,法莫替丁在 5～ 2 0 0 μg·ml- 1 浓度范围内 ,峰面积与浓度线性关系良好 ,相关系数r =0 .9999,平均回收率为 99.4% ,RSD =0 .9%。结论 :本方法可用于法莫替丁咀嚼片的含量测定和有关物质检查。
Objective: To establish RP HPLC for the determination of famotidine chewable tablets. Methods: A Shimpack ODS column (150 mm × 6 mm, 5 μm) was used. The mobile phase was 0.1 mol·L -1 sodium acetate solution (pH 6.0): acetonitrile (92: 8) Flow rate 1.0ml · min-1, detection wavelength 2 66nm. Results: Famotidine was completely separated from the related substances under the selected chromatographic conditions. The excipients did not interfere with the main drug, the concentration of famotidine in the range of 5 ~ 200 μg · ml-1, the peak area The linear relationship was good with the correlation coefficient r = 0.9999, the average recovery was 99.4%, RSD = 0.9%. Conclusion: This method can be used for the determination of famotidine chewable tablets and related substances.