Synthesis and characterization of impurities of Apixaban drug substance—An anticoagulant

Satheesh, D.; Sreenivasulu, B.; Reddy, Bhavanam Sekhara; Reddy, U. Rajasekhar; Saladi, J. S. Chakradhar; Gupta, P. Badrinath; Reddy, Aaramadaka Sunil Kumar; Aegurla, Balakrishna; Basavaiah, K.

doi:10.1002/jhet.4501

Journal of Heterocyclic Chem

2022

DOI: 10.1002/jhet.4501

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Synthesis and characterization of impurities of Apixaban drug substance—An anticoagulant

D. Satheesh

B. Sreenivasulu

Bhavanam Sekhara Reddy

et al.

Abstract: Apixaban is an anticoagulant used to treat venous thromboembolic disorders. The present work describes the origin and synthesis of related substances of Apixaban PG ester‐1 and PG ester‐2. These impurities arise in the process of Apixaban drug substance, later these impurities are transformed into the final Apixaban drug substance. These novel synthesized impurities were characterized by 1H NMR, 13C NMR, HPLC, and HRMS analysis.

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Cited by 2 publications

References 15 publications

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Establishing a multi‐method approach for unprecedented detection and quantification of 13 genotoxic impurities (GTIs) in Apixaban drug substance through ultra‐performance liquid chromatography (UPLC)

Ganta,

Pamerla,

Gunupuru

et al. 2024

Biomedical Chromatography

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This groundbreaking study introduces a pioneering development of multi‐method approach for the first‐ever detection and quantification of 13 genotoxic impurities (GTIs) in Apixaban (Apx) drug substance using ultra‐performance liquid chromatography (UPLC) with ultraviolet (UV) detector. In this novel endeavor, two distinct UPLC‐UV methods, Method A (for impurities A to G) and Method B (for impurities H to M), were meticulously developed and validated as per International Council for Harmonization (ICH) guidelines to address the challenge of identification and control of 13 GTIs in Apx drug substance. The validation process included rigorous assessment of linearity, accuracy, specificity, precision, limit of quantification (LOQ), and limit of detection (LOD) for each impurity in each method which marks a significant advancement in pharmaceutical analysis. The developed methods address the regulatory requirements set forth by ICH M7(R2) guidelines by providing a reliable approach for quantifying GTIs in Apx drug substance at trace levels to minimize the potential carcinogenic risk to the patients.

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Establishing a multi‐method approach for unprecedented detection and quantification of 13 genotoxic impurities (GTIs) in Apixaban drug substance through ultra‐performance liquid chromatography (UPLC)

Ganta,

Pamerla,

Gunupuru

et al. 2024

Biomedical Chromatography

View full text Add to dashboard Cite

show abstract

Synthesis and characterization of potential impurities of ezetimibe

Satheesh

Devi

Basavaiah

et al. 2022

Journal of Heterocyclic Chem

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Ezetimibe is an azetidinone derivative and a substituted β-lactam, it is a hypolipidemic agent, and a drug substance that lowers the cholesterol levels in our body. The present work describes the origin, synthesis, and characterization of three impurities of ezetimibe, which are also positional isomers and/or related substances of ezetimibe. viz: o-Fluoro benzene isomer, m-Fluoro aniline analog, and des-fluoro aniline analogs of ezetimibe.

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Synthesis and characterization of impurities of Apixaban drug substance—An anticoagulant

Cited by 2 publications

References 15 publications

Establishing a multi‐method approach for unprecedented detection and quantification of 13 genotoxic impurities (GTIs) in Apixaban drug substance through ultra‐performance liquid chromatography (UPLC)

Establishing a multi‐method approach for unprecedented detection and quantification of 13 genotoxic impurities (GTIs) in Apixaban drug substance through ultra‐performance liquid chromatography (UPLC)

Synthesis and characterization of potential impurities of ezetimibe

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