HPLC法测定复方丁苓胶囊中法莫替丁含量

Determination of famotidine content of compound Dingling Capsule by HPLC method

目的 采用反相高效液相色谱法（HPLC）建立复方丁苓胶囊中法莫替丁含量测定方法。方法 色谱柱：Kromasil C18柱（150mm×4.6mm,5μm）;流动相：庚烷磺酸钠溶液（取庚烷磺酸钠2.0g,加水900ml溶解后,用冰醋酸调节p H值至3.9,加水至1 000ml）-乙腈（80∶20）为流动相;检测波长：254nm。结果 制剂中辅料对主药测定无干扰,法莫替丁与其他物质成分完全分离;法莫替丁在0.1014-6.084μg范围内具有良好的线性关系。相关系数r=0.9999;平均回收率为98.67%,RSD为2.38%。结论 HPLC法简便、准确、专属性强,可用于复方丁苓胶囊中法莫替丁含量的测定。

Objective By reversed-phase high performance liquid chromatography （HPLC） to establish the determination method of famotidine content in compound Dingling Capsule. Methods The chromatographic column Kromasil C18 column （ 150mm × 4.6mm, 5 microns ） ; Mobile phase ： Sodium heptanesulfonate solution （ Sodium heptanesulfonate 2.0g, add water 900 ml dissolves, with glacial acetic acid to adjust PH value to 3.9, add water to 1000ml）-acetonitrile （80：20） as mobile phase; detection wavelength：254nm. Results There was no interference to the determination of the main drug in the preparation, the famotidine was completely separated from other material composition; Famotidine within 0.1014 -6. 084 μg had a good linear relationship. The correlation coefficient r = 0. 9999 ;The average recovery was 98.67% , RSD was 2.38%. Conclusion HPLC method is simple, accurate and specific, which can be used for content determination of famotidine in com- pound Dingling Capsule.