Development and validation of an LC-MS/MS method for simultaneous determination of three organic azido impurities in tetrazole-containing sartans

Wichitnithad, Wisut; Nantaphol, Siriwan; Thitikornpong, Worathat; Rojsitthisak, Pornchai

doi:10.1016/j.arabjc.2023.104951

Arabian Journal of Chemistry

2023

DOI: 10.1016/j.arabjc.2023.104951

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Development and validation of an LC-MS/MS method for simultaneous determination of three organic azido impurities in tetrazole-containing sartans

Wisut Wichitnithad¹,

Siriwan Nantaphol²,

Worathat Thitikornpong

et al.

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2024

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Cited by 4 publications

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Encequidar Mesylate Novel Degradation Products: Isolation, Characterization, and Structural Evaluation Using Mass‐Triggered Preparative HPLC, HRMS, and NMR Techniques

Surukonti,

Manabolu Surya

2024

Separation Science Plus

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Encequidar mesylate salt is a novel, little‐absorbed P‐glycoprotein (P‐gp) that facilitates oral absorption. It is a substance that stops the P‐gp adenosine triphosphate‐binding cassette transporter from working. To ascertain the drug substance's inherent stability, it underwent stress testing under a variety of degradation conditions, including acidic hydrolysis, alkaline hydrolysis, oxidative, thermal, and photolytic, in accordance with regulatory requirements. It was discovered that the drug substance is highly unstable in alkaline conditions, and the degradation leads to the formation of two unique, unknown degradation products. Utilizing UHPLC–ESI/MS for identification and mass‐triggered preparative HPLC for isolation, the degradants’ structures were definitively determined by using high‐resolution mass spectrometry and 2D NMR methodologies. These unique degradation products were determined to be novel impurities of the encequidar drug substance and were firmly proven to be its hydrolysis components on the basis of spectral and chromatographic data. Possible potential mechanisms have been proposed to explain the formation of the degradants.

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Encequidar Mesylate Novel Degradation Products: Isolation, Characterization, and Structural Evaluation Using Mass‐Triggered Preparative HPLC, HRMS, and NMR Techniques

Surukonti,

Manabolu Surya

2024

Separation Science Plus

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The quality of drugs and drug products – Always guaranteed?

Buschmann,

Handler,

Holzgrabe

2024

Journal of Pharmaceutical and Biomedical Analysis

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Application of advanced high resolution mass spectrometric techniques for the analysis of losartan potassium regarding known and unknown impurities

Backer,

Buschmann,

Kinzig

et al. 2024

Journal of Pharmaceutical and Biomedical Analysis

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Development and validation of an LC-MS/MS method for simultaneous determination of three organic azido impurities in tetrazole-containing sartans

Cited by 4 publications

References 12 publications

Encequidar Mesylate Novel Degradation Products: Isolation, Characterization, and Structural Evaluation Using Mass‐Triggered Preparative HPLC, HRMS, and NMR Techniques

Encequidar Mesylate Novel Degradation Products: Isolation, Characterization, and Structural Evaluation Using Mass‐Triggered Preparative HPLC, HRMS, and NMR Techniques

The quality of drugs and drug products – Always guaranteed?

Application of advanced high resolution mass spectrometric techniques for the analysis of losartan potassium regarding known and unknown impurities

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