The application of quality by design in the development of the liquid chromatography method to determine empagliflozin in the presence of its organic impurities
Joanna Wittckind Manoel, Gabriele Bordignon Primieri, Lívia Maronesi Bueno, Nathalie Ribeiro Wingert, Nádia Maria Volpato, Cássia Virgínia Garcia, Elfrides Eva Scherman Schapoval, Martin Steppe
Abstract
) were determined for EMPA, IMP1 and IMP2, respectively. The HPLC method for impurity determination in empagliflozin was linear, precise, accurate and robust. It can be successfully applied in the quality control of empagliflozin and the synthesis of impurities, being adequate for routine analysis.
Topics & Concepts
EmpagliflozinImpurityQuality by DesignChromatographyChemistryHigh-performance liquid chromatographySolventOrganic chemistryMedicineDiabetes mellitusPhysical chemistryEndocrinologyType 2 Diabetes MellitusParticle sizeDiabetes Treatment and ManagementMetabolism, Diabetes, and CancerPancreatic function and diabetes