HPLC法测定盐酸格拉司琼口服溶液的含量和有关物质  

Determination of Granisetron Hydrochloride Oral Solution and Its Related Substances by HPLC

作　　者：梁艳芳[1] 姜亚莉[2] 罗永慧[1] 魏春燕[1] 王延松[1] 

机构地区：[1]扬子江药业集团有限公司药物研究院,泰州225321 [2]扬州市第一人民医院

出　　处：《中国药事》2012年第4期375-378,共4页Chinese Pharmaceutical Affairs

摘　　要：目的建立HPLC法测定盐酸格拉司琼口服溶液的含量、有关物质。方法参照《中国药典》2010年版二部标准中盐酸格拉司琼检测方法,对盐酸格拉司琼口服溶液的含量和有关物质进行测定。采用Inertsil CN-3氰基柱,流动相:0.25%(mL.mL-1)三乙胺的0.05mol.L-1醋酸钠溶液(用冰醋酸调节pH值至6.0)-甲醇(50∶50),流速:1.0mL.min-1,检测波长:302nm,柱温:25℃。结果盐酸格拉司琼在0.045 6～1.14mg.mL-1范围内呈良好的线性关系(r=1),有关物质各杂质峰与主峰及辅料峰之间的分离度良好,检测限为0.54ng。结论该方法准确、专属性好、灵敏度高,可用于盐酸格拉司琼口服溶液的质量控制。Objective To establish an HPLC method to determine the content and the related substances of Granisetron Hydrochloride Oral Solution.Methods Granisetron hydrochloride oral solution and the related substances were determined according to the quality criteria of granisetron hydrochloride in Chinese Pharmacopoeia 2010 version.The chromatographic method was carried out on Inertsil CN-3 column.The mobile phase was sodium acetate solution（0.05 mol·L-1）containing 0.25%（mL·mL-1）triethylamine（adjusted with glacial acetic acid to pH 6.0）-methanol（50∶50）.The flow rate was 1.0 mL·min-1.The detection wavelength was 302 nm.The column temperature was 25℃.Results The standard curve was linear in the range of 0.045 6~1.14 mg·mL-1（r=1）.The separation among granisetron hydrochloride,its excipients and the related substances is satisfactory.The limit of detection was 0.54 ng.Conclusion The method is accurate,selective,sensitive and suitable to control the quality of Granisetron Hydrochloride Oral Solution.

关 键 词：盐酸格拉司琼口服溶液 HPLC 含量 有关物质 

分 类 号：R927[医药卫生—药学]