RP-HPLC测定复方法莫替丁咀嚼片中法莫替丁的含量及有关物质

 目的 采用反相高效液相色谱法建立复方法莫替丁咀嚼片有关物质检查及其含量测定方法。方法 色谱柱为ShimpackODS柱(150 mm×6 mm,5μm),流动相为:乙腈-0.1 mol·L^-1醋酸钠溶液(含0.1％三乙胺,pH=6.00)(7:93);流速:1.0 mL·min^-1,检测波长:268 nm,柱温40℃。结果 制剂中辅料对主药测定无干扰,法莫替丁与有关物质完全分离;法莫替丁在5～100μg·mL^-1浓度范围内,峰面积与浓度线性关系良好,相关系数r=0.999 9;平均回收率为98.6％(n=9),RSD=0.5％。结论本法简便,准确,专属性强,可用于复方法莫替丁咀嚼片的有关物质检查及含量测定。

Determination of famotidine and related substances in its chewable tablets by RP-HPLC

OBJECTIVE To develop a RP-HPLC method for the determination of famotidine and its related substances. METHODS The chromatographic analysis was performed on a Shimpack ODS column (150 mm× 6 mm, 5μm) with the column temperature at 40℃. The mobile phase consisted of acetonitrile-0.1 mol·L^-1 NaAc (containing 0.1% of triethylamine, the pH adjusted to 6.0 with glacial acetic acid) (7:93). The flow rate was 1.0 m·min^-1 with the detection wavelength at 268 nm. RESULTS The method was validated, and the excipi-ents did not interfere with the determination of famotidine. The standard curve was linear within the range of 5～100μg·mL^-1 with the correlation coefficient of 0.999 9. The average recovery was 98.6 % (RSD = 0.5%). CONCLUSION This method was simple, accurate, specific and may be used for the quality control of compound famotidine chewable tablets.