G - Physics – 01 – N
Patent
G - Physics
01
N
G01N 30/34 (2006.01) G01N 33/94 (2006.01)
Patent
CA 2703762
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.
L'invention porte sur de nouveaux procédés de chromatographie liquide à haute pression (HPCL) permettant d'analyser l'ingrédient pharmaceutique actif formotérol et des substances liées. Selon un premier procédé de l'invention, la phase mobile comprend au moins deux liquides, la concentration des liquides variant selon un gradient prédéterminé. Selon un second procédé de l'invention, la phase mobile comprend un premier liquide A renfermant une solution aqueuse d'acétate d'ammonium et un second liquide B renfermant un solvant aprotique dipolaire. Selon un troisième procédé, la phase mobile comprend un premier liquide A renfermant une solution aqueuse d'acétate d'ammonium d'une concentration comprise entre 0,001 et 0,025, et un second liquide B. L'invention se rapporte également à un procédé d'analyse d'une substance, qui consiste à détecter et, facultativement, à quantifier la présence d'une ou plusieurs impuretés spécifiques.
Dhore Dilip
Kumar E.k.s. Vijaya
Patil Sachin
Samel Amit
Generics [uk] Limited
Osler Hoskin & Harcourt Llp
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