CONTRIBUTIONS TO QUALITY CONTROL BY HPLC OF FIXED COMBINATIONS WITH PIOGLITAZONE AND METFORMIN
Abstract:
The purpose of this study was to develop a reversed-phase HPLC method for the simultaneous
determination of metformin and pioglitazone in pharmaceutical dosage forms and impurities HPLC
profiling of two pioglitazone and three metformin impurities, in the presence of their parent compound.
The analytical methods were developed following an optimization from different aspects of the methods
available in the correspondent monographs of the European Pharmacopoeia 10.1 edition and that of the
United States Pharmacopoeia 43. A C18 column stationary phase and an ion pair former were used to
improve the retention of hydrophillic analytes and the most suitable detection wavelength was set at 255
nm. The method was tested by quantitative estimation of active substances from a mixture of commercial
tablet powder obtained in a 500:15 metformin:pioglitazone mass ratio. The method for separation of
impurities proved to be satisfactory in terms of resolution between peaks, but not in terms of separation
efficiency for metformin impurities.
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