摘要
目的建立高效液相色谱法测定法莫替丁有关物质的方法。方法采用C18色谱柱,流动相采用乙酸盐缓冲液(pH 6.0)-乙腈,梯度洗脱,流速为1.5mL·min-1,检测波长为270nm,柱温为35℃。结果在该色谱条件下,法莫替丁与有关物质分离度良好,能有效检出法莫替丁的降解产物。结论该方法能够检测出法莫替丁的降解情况,对药品质量进行有效控制。
Objective To establish a method to detect the related substances in Famotidine by HPLC. Methods The C18 column was used. The mobile phase was composed of acetate buffer acetate （pH 6.0） and acetonitrile as gradient elute. The flow rate was 1.5 mL·min^-1. The detective wavelength was set at 270 nm and the column temperature was 35 ℃. Results Under this chromatographic condition, the related substances were completely separated from Famotidine and the degradation products could be determined by HPLC. Conclusion The HPLC method can determine the situation of degradation of Famotidine, which meets the requirement of quality control.
出处
《中国药事》
CAS
2014年第2期195-197,共3页
Chinese Pharmaceutical Affairs
