HPLC法测定盐酸格拉司琼口服溶液的含量和有关物质

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0.05 mol· L-1醋酸钠溶液(用冰醋酸调节pH值至6.0)-甲醇(50∶ 50),流速:1.0 mL·min-1,检测波长:302 nm,柱温:25℃.结果 盐酸格拉司琼在0.045 6～1.14 mg· 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0.54 ng.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.

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

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.