关键词: font-size:medium, ">法莫替丁；有关物质；杂质；高效液相色谱；质量控制

Abstract: Objective： To establish an HPLC method for the detection of related substances in Famotidine Injection and Famotidine Tablets. Methods： The chromatographic column was Kromasil 100-5-C18(4.6 mm×250 mm， 5μm). Mobile phase A was 0.01 mol·L-1 sodium heptane sulfonate(pH was adjusted to 3.5 by glacial acetic acid)， mobile phase B was acetonitrile， gradient elution. The flow rate was 1.0 mL·min-1， the column temperature was 30 ℃， the detection wavelength was 266 nm， and the Injection volume was 20 μL. Results： Famotidine peak was well separated from adjacent impurity peaks and between each impurity peaks； The blank excipients did not interfered the detection of impurities. The determination of each impurity was not affected by acid， alkali， light， ultraviolet， high temperature or oxidation destruction； Famotidine and each impurity showed a good linear relationship with the corresponding peak areas within a certain concentration range(r2≥0.999). Detection limit of each component were between 0.003% and 0.027%. The recovery rate of each impurity was between 91.0% and 103.7%(n=9， RSD＜4.0%). The results of repeatability test， precision test and durability test were all well. Nine batches of samples were measured， each impurity was between 0.03% and 1.0%， and the total amount of impurities were between 0.4% and 2.0%. Conclusion： This method is efficient， selective， and sensitive， and can be used for the determination of related substances in famotidine injection and famotidine tablets.
    

Key words: font-size:medium, ">Famotidine； Related substances； Impurities； High-performance liquid chromatography（HPLC）； Quality control