摘要
采用反相高效液相色谱法对新药盐酸度洛西汀片的含量及其有关物质进行了测定:选用Kromasil—C_(18)柱(250 mm×4.6 mm×5μm),乙腈-0.01 mol/L磷酸二氢钾(52:48)(pH=7.7,三乙胺调节)为流动相,流速1.0 mL/min,检测波长230 nm.盐酸度洛西汀在5.085~81.360 mg/L范围内,含量与峰面积线性关系良好,回归方程A=71 542C+65.56,r=0.999 9,平均回收率为99.88%,RSD=0.25%.本法简便快速、准确、专属性强.
To establish a RP- HPLC method for determination of duloxetine hydrochloride tablets and its related substances, the RP - HPLC condition consisted of a Kromasil - CT8 column ( 250 mm × 4. 6 mm × 5 μm), mobile phase of acetonitrile - 0. 01 mol/L potassium dihydrogen phosphate buffer ( 52 : 48 ) (pH = 7.7,adjusted with triethylamine) with a flow rate of 1.0 mL/min, and a detection wavelength at 230 nm. The linearity of duloxetine hydrochloride concentration was within 5. 085 - 81. 360 mg/L and the regression equation being A = 71 542C + 65.56, r = 0. 999 9. The average recovePy was 99.88%, RSD = 0. 25%. The specific, reliable and accurate RP - HPLC method is applied to quality control of duloxetine hydrochloride tablets and the related substances.
出处
《郑州轻工业学院学报(自然科学版)》
CAS
2008年第5期21-23,共3页
Journal of Zhengzhou University of Light Industry:Natural Science