CAJ | 학술논문

目的：优化并建立准确灵敏的乌苯美司片的有关物质检查方法。方法：比较国家标准YBH05722010和YBH07102009中有关物质检查方法在检测波长、配制溶剂、供试品溶液浓度、记录时间和辅料峰是否扣除上存在的差异，优化检查方法：C18柱，以甲醇-0.6％磷酸二氢钠溶液（45∶55）为流动相，柱温40℃，流量1.0 mL · min-1，检测波长220 nm。结果：按照标准YBH05722010中方法检测到的杂质个数和杂质总量均大于按照标准YBH07102009中方法测定的结果。方法优化后乌苯美司峰与辅料峰及各降解产物峰均能良好分离，供试品溶液在24 h内基本稳定，检测限为1.854 ng。结论：优化后方法灵敏度高，专属性强，结果准确，能更好地测定乌苯美司片的有关物质。
목적：우화병건립준학령민적오분미사편적유관물질검사방법。방법：비교국가표준YBH05722010화YBH07102009중유관물질검사방법재검측파장、배제용제、공시품용액농도、기록시간화보료봉시부구제상존재적차이，우화검사방법：C18주，이갑순-0.6％린산이경납용액（45∶55）위류동상，주온40℃，류량1.0 mL · min-1，검측파장220 nm。결과：안조표준YBH05722010중방법검측도적잡질개수화잡질총량균대우안조표준YBH07102009중방법측정적결과。방법우화후오분미사봉여보료봉급각강해산물봉균능량호분리，공시품용액재24 h내기본은정，검측한위1.854 ng。결론：우화후방법령민도고，전속성강，결과준학，능경호지측정오분미사편적유관물질。
Objective:To optimize and establish a method for the determination of related substances in Ubenimex tablets .Methods:The detection wavelength , dissolving solvents , concentration of sample solution , recording time and deduction of adjuvant were com-pared between the two government standards of YBH 05722010 and YBH07102009.The optimized RP-HPLC was performed on C 18 col-umn and the mobile phase was methanol-0.6%sodium dihydrogen phosphate solution (45∶55) with a flow rate of 1.0 mL· min-1, the temperature of column was 40 ℃and the detection wavelength was 220 nm.Results:The numbers and total amount of impurities determined according to YBH 05722010 were both more than that determined according to YBH 07102009.In optimized method , Uben-imex peak was completely separated from peaks of adjuvant and degraded impurities , the limit of detection was 1.854 ng and the solu-tion was stable for 24 h.Conclusion:The optimized method is specific , sensitive, accurate and can be used for the determination of related substances of Ubenimex tablets better.