摘要
建立了盐酸度洛西汀肠溶胶囊的溶出测定方法,并筛选出能够指导体内外相关性的溶出曲线,用于仿制药的一致性评价,为体内外相关性提供数据支持。采用Aglient ZORBAX SB-C8柱(75 mm×4.6 mm×3.5μm),流动相为磷酸盐缓冲液-甲醇-四氢呋喃(体积比为587∶323∶90),流速为1.0 ml/min,检测波长为230nm,柱温为45℃。在0.006~0.075 mg/m L范围内,盐酸度洛西汀质量浓度与峰面积呈线性关系,回收率在99.5%~102.2%之间。参照《仿制药生物等效性指导原则》筛选出4种介质用于注册批样品稳定性检测,其液相色谱检测方法具有准确和快速等特点。
A dissolution determination method for duloxetine hydrochloride enteric-coated capsules was established,and the dissolution curve which can guide the correlation between in vivo and in vitro was selected, so as to evaluate the consistency of generic drugs and provide data support for the correlation between in vivo and in vitro. Aglient ZORBAX SB-C8(75 mm×4.6 mm×3.5 μm) was used, the mobile phase was phosphate buffer-methanol-tetrahydrofuran(the volume ratio was 587∶323∶90), the flow rate was 1.0 mL/min, the detection wavelength was 230 nm, and the column temperature was 45 ℃. The linear range of the method was 0.006-0.075 mg/mL, and the recovery rate was 99.5%-102.2%. Four kinds of media were screened out according to the Guiding Principles of Bioequivalence of Generic Drugs for the stability test of registered batches, and the liquid chromatography detection method was accurate and rapid.
出处
《上海化工》
CAS
2022年第6期58-61,共4页
Shanghai Chemical Industry
