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目的建立HPLC法测定曲匹布通片含量及溶出度。方法选用PhenomenexCl8柱(250mm×4.60mm,5um),甲醇一醋酸钠缓冲液(取醋酸钠6.13g,加水750ml,加冰醋酸调节pH值至2.5)(60:40)为流动相,检测波长为271nm,流速:1.0mL.min-1,柱温:35℃。结果曲匹布通在7.48～37.42ug.mL-1范围内,线性关系良好,F0.9999,平均回收率为98.9%。结论该法简便、准确、专属,可用于该片的质量控制。
Objective To establish HPLC method for the determination of content and dissolution of trabupram tablet. Methods PhenomenexCl8 column (250mm × 4.60mm, 5um) was used as the mobile phase. The mobile phase consisted of methanol-sodium acetate buffer (6.13g, sodium acetate, 750ml, glacial acetic acid, pH = 2.5) 271 nm, flow rate: 1.0 mL.min-1, column temperature: 35 ° C. Results The results showed that in the range of 7.48 ~ 37.42 ug.mL-1, the content of trabupram was good and the linear relationship was good. The average recovery was 98.9%. Conclusion The method is simple, accurate and exclusive and can be used for the quality control of the film.