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作 者:杨清清[1] 刘文英[2] 狄斌[2] 苏梦翔[2]
机构地区:[1]江苏省药品检验所,南京210008 [2]中国药科大学药物分析教研室,南京210009
出 处:《中国药科大学学报》2007年第2期136-139,共4页Journal of China Pharmaceutical University
摘 要:目的:建立盐酸雷莫司琼中S-异构体检查的高效毛细管电泳方法。方法:采用石英毛细管柱(50μm×50 cm,有效长度41.5 cm),运行缓冲液为20 mmol/L的磷酸二氢钠溶液(含1%的磺化-β-环糊精,磷酸调pH至3.0)。操作电压为-20 kV,柱温为25℃,检测波长为210 nm。结果:S-异构体和R-异构体的分离度为8.2,线性范围4.048-80.96μg/mL,平均回收率为99.80%,检测限为2μg/mL。结论:所建立的高效毛细管电泳方法灵敏、简便、准确、可靠,适用于盐酸雷莫司琼中S-异构体的检查。Aim: To develop a high performance capillary electrophoresis (HPCE) method for the chiral separation of S-enantiomer in ramosetron hydrochloride. Methods: The enantiomers were separated by HPCE on a capillary (50 cm×50μm, ID) with the running buffer solution of 20 mmol/L of sodium dihydrogen phosphate, which contained 1% sulfated-β-cyclodextrin and was adjusted to pH 3.0 with phosphoric acid. The operating voltage was - 20 kV and the column temperature was 25 ℃ with UV wavelength of 210 nm. Results: The resolution between S-isomer and R- isomer was about 8.2 at the optimized conditions. The linearity between concentrations and peak area was obtained from 4.048 - 80.96 μg/mL. The average recovery was 99.80% and the limit of detection was 2 μg/mL. Conclusion: The established HPCE method is simple, accurate and reliable. It is suitable for the detection of S-enantiomer in ramosetron hydrochloride.
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