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目的:建立测定西咪替丁片剂含量的高效液相色谱法。方法:选用Agilent Eclipse XDB-C8柱(4.6mm×250mm,5μm);Lab Alliance C8保护柱(4.6mm×10mmi.d,5μm);流动相:甲醇-水=18∶82(含20mmol.L-1乙酸/乙酸钠缓冲溶液,pH5.0);流速:1.0mL·min-1;检测波长:230nm;进量样:20μL;柱温:室温。结果:方法的线性范围为10.0～300μg·mL-1(r=0.9995);最低检测限2.0ng。常州样品的回收率在98.9%～101%之间,RSD为2.05%～3.75%(n=5);鄂州样品的回收率在97.9%～101%之间,RSD为1.94%～2.62%(n=5)。结论:方法简便灵敏,结果准确可靠,可用于西咪替丁片剂的质量控制。
Objective: To establish a HPLC method for the determination of cimetidine tablets. Methods: The Agilent Eclipse XDB-C8 column (4.6 mm × 250 mm, 5 μm) was used. The Lab Alliance C8 guard column (4.6 mm × 10 mm i.d, 5 μm) was used. The mobile phase was methanol- water = 18:82 1 acetic acid / sodium acetate buffer solution, pH 5.0); flow rate: 1.0 mL · min -1; detection wavelength: 230 nm; Results: The linear range of the method was 10.0 ~ 300μg · mL-1 (r = 0.9995). The minimum detection limit was 2.0ng. The recoveries of Changzhou samples ranged from 98.9% to 101% with RSDs of 2.05% to 3.75% (n = 5). The recoveries of samples from Ezhou ranged from 97.9% to 101% with RSDs ranging from 1.94% to 2.62% (n = 5). Conclusion: The method is simple and sensitive, the results are accurate and reliable, and can be used for the quality control of cimetidine tablets.