Simultaneous Quantitative Analysis of Polymorphic Impurities in Canagliflozin Tablets Utilizing Near-Infrared Spectroscopy and Partial Least Squares Regression.

ABSTRACT: Canagliflozin (CFZ), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, is extensively utilized in the management of type 2 diabetes. Among its various polymorphic forms, the hemi-hydrate (Hemi-CFZ) has been selected as the active pharmaceutical ingredient (API) for CFZ tablets due to its superior solubility. However, during the production, storage, and transportation of CFZ tablets, Hemi-CFZ can undergo transformations into anhydrous (An-CFZ) and monohydrate (Mono-CFZ) forms under the influence of environmental factors such as temperature, humidity, and pressure, which may adversely impact the bioavailability and clinical efficacy of CFZ tablets. Therefore, it is imperative to develop rapid, accurate, non-destructive, and non-contact methods for quantifying An-CFZ and Mono-CFZ content in

SUBMITTER: Liu M 

PROVIDER: S-EPMC12843906 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature