HPLC法测定盐酸度洛西汀肠溶胶囊有关物质

Determination of Related Substances in Duloxetine Hydrochloride Enteric-coated Capsules by HPLC

建立了盐酸度洛西汀有关物质测定的高效液相色谱(HPLC)方法。采用ZorbaxSB-C8柱(4.6 mm×75 mm,3.5μm),以磷酸盐缓冲液-甲醇-四氢呋喃(体积比为587∶323∶90)为流动相,在检测波长为230 nm的条件下:主药和有关物质能较好地分离,在38.8～155.2μg/mL(r=1.000 0,n=8)内,度洛西汀质量浓度与峰面积线性关系良好;分别在0.08～0.33μg/mL(r=0.999 9,n=8)和0.08～0.32μg/mL(r=0.999 7,n=8)内,杂质Ⅲ和Ⅷ的质量浓度与峰面积呈良好的线性关系。该方法简便、准确、可行、精密度高,可用于盐酸度洛西汀肠溶胶囊有关物质的质量控制。

The paper established a method for the determination of duloxetine and related substances in duloxetine hydrochloride enteric-coated capsule by high performance liquid chromatography(HPLC).The test was performed in a ZorbaxSB-C8column(4.6mm×75mm,3.5μm)with phosphate buffer-methanol-tetrahydrofuran(the volume ratio was587︰323︰90)as a mobile phase at the detected UV wavelength of230nm.The resolution between duloxetine hydrochloride and the other peaks met the requirements.The standard curves of duloxetine hydrochloride and the related substanceⅢandⅧshowed a good linearity in the range of38.8-155.2g/mL,0.08-0.33g/mL and0.08-0.32g/mL,respectively.This method is simple,accurate,feasible and higher precise,it can be used for the quality control of the related impurities in duloxetine hydrochloride enteric-coated capsule.