盐酸格拉司琼喷剂质量分析

Quality Analysis of Granisetron Hydrochloride Spray

目的研究盐酸格拉司琼喷剂质量控制方法 ,为制订质量标准提供技术依据。方法采用HPLC法测定含量,并控制每瓶总喷次和每喷主药含量。色谱柱为氰基硅烷键合硅胶柱;流动相:含0.25%(mLmL-1)三乙胺的0.05molL-1醋酸钠溶液-甲醇(50:50);检测波长:302nm。结果盐酸格拉司琼浓度在22～114μgmL-1范围内线性关系良好,回收率为100.13%,RSD为0.90%。结论所建立质量控制方法合理、可靠,重复性好,可用于盐酸格拉司琼喷剂的质量控制。

Objective Granisetron hydrochloride spray quality control methods, to provide the technical basis, for the development of quality standards. Methods HPLC determination of content, detecting the total spray times in each bottle and testing each spray drug content. The chromatographic column was cyanosilane bonded silica gel column; mobile phase containing 0.25% （mL.mL-1） triethylamine in 0.05 tool.L-1 sodium acetate solution-methanol （50：50）; detection wavelength： 302 nm. Rosults Granisetronhydrochloridein22-1141μomL-1 concentration range was linear relationship, recovery 100.13 %, RSD 0.90 %. Conclusions Established a reasonable method of quality control, reliable, reproducible and can be used for quality control of granisetron hydrochloride spray.