Evidence map›Paper›PMID 41599279›Full record

ArticleMolecules (Basel, Switzerland)2026

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

Mingdi Liu, Rui Fu, Guiyu Xu, Weibing Dong, Huizhi Qi, Peiran Dong, Ping Song

Abstract read
In one paragraph

Article in Molecules (Basel, Switzerland), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

7 authors.

Mingdi LiuCollege of Chemistry and Materials Science, Qinghai Minzu University, Xining 810007, China.
Rui FuCollege of Chemistry and Materials Science, Qinghai Minzu University, Xining 810007, China.
Guiyu XuCollege of Chemistry and Materials Science, Qinghai Minzu University, Xining 810007, China.
Weibing DongCollege of Chemistry and Materials Science, Qinghai Minzu University, Xining 810007, China.
Huizhi QiCollege of Chemistry and Materials Science, Qinghai Minzu University, Xining 810007, China.
Peiran DongCollege of Chemistry and Materials Science, Qinghai Minzu University, Xining 810007, China.
Ping SongCollege of Chemistry and Materials Science, Qinghai Minzu University, Xining 810007, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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 CFZ tablets to control polymorphic impurity levels and ensure product quality. This research evaluated the feasibility and reliability of using near-infrared spectroscopy (NIR) combined with partial least squares regression (PLSR) for simultaneous quantitative analysis of An-CFZ and Mono-CFZ in CFZ tablets, elucidating the quantifying mechanisms of the quantitative analysis model. Orthogonal experiments were designed to investigate the effects of different pretreatment methods and ant colony optimization (ACO) algorithms on the performance of quantitative models. An optimal PLSR model for simultaneous quantification of An-CFZ and Mono-CFZ in CFZ tablets was established and validated over a concentration range of 0.0000 to 10.0000 w/w%. The resulting model, Y

Indexed as

CanagliflozinDrug ContaminationBulk DrugsLeast-Squares AnalysisReproducibility of ResultsSpectroscopy, Near-InfraredTabletsBulk DrugsCanagliflozinTabletsACOcanagliflozinNIRPLSRquantitative mechanism

Identifiers

PMID41599279
PMCPMC12843906

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.