HPLC测定盐酸格拉司琼葡萄糖注射液中盐酸格拉司琼含量及有关物质

采用氰基硅烷键合硅胶柱(250 mm×4.6 mm,5μm),以0.05 mol/L醋酸钠缓冲液[含0.25%(mL/mL)三乙胺,用冰醋酸调节pH值至6.0]-甲醇(50∶50)为流动相;在0.8 mL/min的流速和302 nm的检测波长下用高效液相色谱方法测定盐酸格拉司琼葡萄糖注射液中盐酸格拉司琼含量及有关物质。结果表明,盐酸格拉司琼在19.8～46.2μg/mL浓度范围内呈现出良好线性关系,线性相关系数为0.999 6,平均回收率是98.18%,RSD是1.32%,且5-羟甲基糠醛在4～14μg/mL浓度范围内呈现出良好线性关系,线性相关系数为0.999 8,检出限为1ng。同时,各杂质均可与盐酸格拉司琼主峰良好分离。该方法简便、快速、准确、专属性强及灵敏度高。

Determination of granisetron hydrochloride and its related substances in granisetron hydrochloride and glucose injection by HPLC

HPLC was applied to determine granisetron hydrochloride and its related substances in granisetron hydrochloride and glucose injection.The chromatographic column was cyanosilane bonded silica gel column(250 mm ×4.6 mm,5 μm).The mobile phase consisted of 0.05 mol/L sodium acetate buffer(contain 0.25% triethylamine,glacial acetic acid to adjust pH value of 6.0) and methanol.The flow rate was 0.8 mL/min,and the detection wavelength was 302 nm.The results show that the linear range of granisetron hydrochloride was 19.8～46.2 μg/mL,r=0.999 6,the average recovery was 98.18%,and RSD was 1.32%,the linear range of 5-HMF was 4.0～14.0 μg/mL,r=0.999 8,LOD=1 ng.Meanwhile,the peaks between granisetron hydrochloride and impurities were seperated well.This method had a wide linear range,low relative standard deviation,high precision and obtained satisfactory results.