The present invention relates tonovel HPLC methods for the analysis of the API formoterol 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 first liquid A comprising an aqueous solution of ammonium acetate and a second liquid B comprising a dipolar aprotic solvent. In a third method the mobile phase comprises a first liquid A comprising an aqueous solution of ammonium acetate with a concentration of 0.001 to 0.025M, and a second liquid B. 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
WO2009056872(A2)
申请公布日期
2009.05.07
申请号
WO2008GB50963
申请日期
2008.10.18
申请人
GENERICS [UK] LIMITED;MYLAN DEVELOPMENT CENTRE PRIVATE LIMITED;KUMAR, E.K.S. VIJAYA;SAMEL, AMIT;PATIL, SACHIN;DHORE, DILIP