Simultaneous Determination of 3 Optical Isomers in Carfilzomib by HPLC / 中国药师

ABSTRACT

Objective:To establish an HPLC method for the determination of optical isomers in carfilzomib .Methods:The sample was separated on a Chiralpak OX-H column.The mobile phase consisted of n-hexane∶isopropanol∶alcohol (89 ∶5 ∶6, v/v/v) with a flow rat of 1.0 ml· min-1 .The detection wavelength was 220 nm.Results:The linear rang of enantiomer , diastereomer Ⅰand di-astereomer Ⅱwas 0.54-2.14 μg· ml -1,0.11-1.80 μg· ml-1 and 0.11-1.81 μg· ml-1(r≥0.998), respectively.The lower limit of quantification was 0.07-0.27 μg· ml-1 .The recoveries of optical isomers were within the range of 99.6%-100.9% with RSD of 1.13%-1.59%(n=9).Conclusion:The method is sensitive, simple, fast, accurate and specific, and suitable for the study of opti-cal isomers in carfilzomib .