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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 for the determination of granisetron hydrochloride oral solution, the related substances. Methods The content and related substances of granisetron hydrochloride oral solution were determined with reference to the method of granisetron hydrochloride in the two standards of Chinese Pharmacopoeia 2010 edition. The mobile phase consisted of a 0.25% (mL.mL-1) triethylamine in 0.05 mol. L-1 sodium acetate solution (adjusted to pH 6.0 with glacial acetic acid) -methanol (50:50 ), Flow rate: 1.0 mL.min-1, detection wavelength: 302 nm, column temperature: 25 ° C. Results Granisetron hydrochloride showed a good linear relationship (r = 1) in the range of 0.045 6-1.14 mg · mL-1. The separation of the impurity peaks from the main peak and the excipient peak was good with the detection limit of 0.54 ng. Conclusion The method is accurate, specific and sensitive. It can be used for quality control of oral solution of granisetron hydrochloride.