法莫替丁氯化钠注射液质量标准的相关研究

Study of quality standard about the Injection of Famotidine and Sodium Chloride

目的建立法莫替丁氯化钠注射液中法莫替丁含量及有关物质检测的高效液相色谱方法.方法采用Agilent ZORBAX SB-C18(4.6×250mm,5μm)色谱柱,以0.2%(g·L-1)庚烷磺酸钠溶液(用冰醋酸调pH值为3.7)-乙腈-甲醇(33∶7∶3)为流动相,流速1.2mL·min-1,柱温为35℃,检测波长为254nm.结果法莫替丁的浓度在0.0794～0.238mg·L-1范围内有良好的线性关系,r=0.9999,样品的平均回收率为99.58%,RSD为0.91%.结论高效液相色谱法测定法莫替丁氯化钠注射液中的法莫替丁含量和有关物质,方法准确度、精密度高,适合应用于该制剂的质量控制.

OBJECTIVE To establish an HPLC method for the determination of famotidine in Injection of Famotidine and Sodium Chloride and its related substances. METHODS Chromatograghie column was Agilent ZORBAX SB--C18 （4.6×250mm,5μm）,the mobile phase consisted of 0.2 % Sodium 1--heptanesulfonate （adjusted pH3. 7 with glacial aceti acid）--acetonitrile--methanol（33 ： 7 ： 3）,the flow rate was 1.2mL ·min^-1 and detection wavelength was 254nm. RESULTS Relationship was observed in the famotidine concentration range of 0. 0794-0. 238mg ·L^-1 with the correlation coefficien of 0. 9999, the average recovery of famotidine was 99.58%, RSD was 0. 91%. CONCLUSION The study shows that we can detect the content of the famotidine and related substances of the Injection of Famotidine Sodium Chloride with HPLC. The methods had very good accuracy and preclsion,it was suitable for the quality control of the Injection of Famotidine Sodium Chloride.