CAJ | 학술논문

目的：：建立HPLC法同时测定盐酸鲁拉西酮中4种光学异构体的含量测定方法。方法：手性柱为CHIRALPAK AD-H (250 mm ×4.6 mm,5μm)；以正己烷∶乙醇∶二乙胺(90∶10∶0.1)为流动相,检测波长为230 nm,柱温为40℃。结果：4种光学异构体之间分离度均大于2.0,线性范围为5~120μg· ml-1,r=0.9999,方法准确度>99.0%, RSD<0.5%,检出限为5 ng。结论：方法简便、准确、快速,适用于含量测定与质量控制。
목적：：건립HPLC법동시측정염산로랍서동중4충광학이구체적함량측정방법。방법：수성주위CHIRALPAK AD-H (250 mm ×4.6 mm,5μm)；이정기완∶을순∶이을알(90∶10∶0.1)위류동상,검측파장위230 nm,주온위40℃。결과：4충광학이구체지간분리도균대우2.0,선성범위위5~120μg· ml-1,r=0.9999,방법준학도>99.0%, RSD<0.5%,검출한위5 ng。결론：방법간편、준학、쾌속,괄용우함량측정여질량공제。
Objective:To establish the determination method for four lurasidone hydrochloride enantiomers by HPLC. Methods:Lurasidone hydrochloride enantiomers were separated on a CHIRALPAK AD-H column (250 mm × 4. 6 mm, 5μm). The mobile phase consisted of hexane-ethanol-diethylamine ( 90∶10∶0. 1) at a flow rate of 1. 0 ml·min-1 and the column temperature was at 40℃. The detection wavelength was 230nm. Results:The resolution of lurasidone hydrochloride enantiomers was above 2. 0. The linear calibra-tion curves were obtained over the range of 5-120 μg· ml-1 for all the enantiomers (r=0. 999 9). The recovery was above 99. 0%with RSD below 0. 5%. The detection limits were 5ng. Conclusion:The method is simple, accurate and rapid, and suitable for the de-termination and quality control.