Development and Validation of HPLC Method for Determination of Trace Level Potential Genotoxic Hydroperoxide Impurity in Canagliflozin

Gosar, Amit; Shaikh, Tabrez; Botkondle, Suresh; Mahadik, Neelam; Tole, Rahul

doi:10.21276/ijprhs.2019.05.05

Cited by 2 publications

(1 citation statement)

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“…For confirmation and identification reasons, GC combined with GC-MS or GC-MS/MS has recently attracted interest, demonstrating the adaptability of this technology. [26][27][28][29] PGIs can be derived to create noticeable species if they are labile, lack chromophores, and have reactive functional groups. [30] The derivatization reagent can be chosen depending on the functional groups of the analyte.…”

Section: Mass Spectroscopy (Ms)mentioning

confidence: 99%

Analytical Methods and Their Significance in Pharmaceutical Process Impurities: A Review

Kumari,

Tripathy,

Gupta

2024

Macromolecular Symposia

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Potential genotoxic substances in medicines are of rising concern to pharmaceutical and regulatory authorities at detectable levels due to their potential to induce human carcinogenesis. Molecule functional groups may contribute to the genotoxicity of small molecules by converting starting materials and synthetic intermediates into reactive components. It is challenging for the pharmaceutical research and development analytical community to identify these genotoxic chemicals at trace levels without using susceptible and selective analytical methods. The literature currently needs more experimental advice for analyzing some significant contaminants. Analytical methods play a vital role in the pharmaceutical industry for monitoring and controlling impurities in drug products. These methods provide critical information on the final product's quality, purity, and efficacy by identifying unwanted substances such as degradation products, residual solvents, and process contaminants. The significance of analytical methods in pharmaceutical process impurities includes ensuring quality control, regulatory compliance, process optimization, troubleshooting, and batch release. These methods help to ensure that the final product meets the required specifications, complies with regulatory requirements, and provides the safe and effective patient treatment. The study analyses the structural alarms of commonly encountered likely genotoxic contaminants and draught regulations of various regulatory authorities to restrict the number of impurities in medicinal substances and to identify their toxicity.

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Section: Mass Spectroscopy (Ms)mentioning

confidence: 99%

Analytical Methods and Their Significance in Pharmaceutical Process Impurities: A Review

Kumari,

Tripathy,

Gupta

2024

Macromolecular Symposia

View full text Add to dashboard Cite

show abstract

Identification of Two Novel Hydroperoxide Impurities in Fluocinolone Acetonide Topical Solution by Liquid Chromatography Mass Spectrometry

Kavitapu

Jaishetty

Maruthapillai

et al. 2023

Journal of Chromatographic Science

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Fluocinolone acetonide topical is used to treat skin discomforts such as swelling, itching and redness by activating the natural substances in the skin. Several process-related impurities and degradation products are identified and reported. But hydroperoxide impurities in Fluocinolone acetonide topical solution are not reported anywhere. In this study, we identify two potential genotoxic isomeric hydroperoxide impurities in Fluocinolone acetonide topical solution by Liquid Chromatography Mass Spectrometry analysis. A possible mechanism for the formation of these two novel hydroperoxide impurities is based on the neighboring group participation effect of adjacent hydroxyl group (Internal SN2) which results in the loss of fluorine atom and formation of epoxide intermediate followed by the addition of the HOOH group. Since most of the hydroperoxide impurities are genotoxic in nature, one should eliminate these impurities from Active Pharmaceutical Ingredient (API) or protect the formulation product from these oxidative impurities.

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Development and Validation of HPLC Method for Determination of Trace Level Potential Genotoxic Hydroperoxide Impurity in Canagliflozin

Cited by 2 publications

References 0 publications

Analytical Methods and Their Significance in Pharmaceutical Process Impurities: A Review

Analytical Methods and Their Significance in Pharmaceutical Process Impurities: A Review

Identification of Two Novel Hydroperoxide Impurities in Fluocinolone Acetonide Topical Solution by Liquid Chromatography Mass Spectrometry

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