The present invention relates to new HPLC methods for the analysis of the drug substance clopidogrel and related substances. In a first method the mobile phase comprises two or more liquids, and the relative concentration of the liquids is varied to a predetermined gradient. In a second method the mobile phase comprises a polar protic organic solvent, and the stationary phase comprises a gel. The present invention also relates to a method for analysing a substance, comprising the detection and optional quantification of one or more specific impurities.
申请公布号
WO2009077784(A2)
申请公布日期
2009.06.25
申请号
WO2008GB51186
申请日期
2008.12.12
申请人
GENERICS [UK] LIMITED;MYLAN DEVELOPMENT CENTRE PRIVATE LIMITED;VIJAYAKUMAR, E. K. S.;AREKAR, J. C.;PATIL, S. S.;DALVI, J. D.;DHORE, D. M.
发明人
VIJAYAKUMAR, E. K. S.;AREKAR, J. C.;PATIL, S. S.;DALVI, J. D.;DHORE, D. M.