LC–MS/MS monitoring of 22 illegal antihistamine compounds in health food products from the Korean market

Kim, Jung Yeon; Choi, Ji Yeon; Yoon, Chang Yong; Cho, Soo-Yeul; Kim, Woo Seong; Ah, Jung

doi:10.1007/s13765-015-0004-3

Cited by 6 publications

(1 citation statement)

References 12 publications

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“…It is used as nasal sprays for treating seasonal allergic rhinitis and non-allergic vasomotor rhinitis. [1][2][3][4] Literature search relating to analytical method development and validation studies on azelastine retrieved several reports, and most of the analytical methods have been developed for AZN in bulk and in its dosage forms, [5][6][7][8] dietary supplements, 9 and food products. 10 A couple of studies utilizing liquid chromatographic-tandem mass spectrometric methods for the determination of AZN have been reported.…”

Section: Introductionmentioning

confidence: 99%

Method validation and characterization of stress degradation products of azelastine hydrochloride using LC‐UV/PDA and LC‐Q/TOF‐MS studies

Shekhar,

Bali

2024

Rapid Comm Mass Spectrometry

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RationaleAzelastine HCl is a second‐generation H1‐receptor antagonist approved by the US Food and Drug Administration (US FDA) for treating seasonal allergic rhinitis and non‐allergic vasomotor rhinitis. This study encompasses the validation of a liquid chromatography‐ultra violet photo diode array (LC‐UV/PDA) method for the drug and its extension to liquid chromatography/quadrupole time‐of‐flight mass spectrometry (LC‐Q/TOF‐MS) studies for identification and characterization of various stress degradation products of the drug.MethodsStress degradation of azelastine HCl was undertaken under the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) prescribed conditions of hydrolytic, photolytic, oxidative, and thermal stress. The degraded drug solutions were analyzed using Ultra Performance Liquid Chromatography (UPLC) employing a C18 (100 × 4.6 mm; 2.6 μ, Kinetex) column by isocratic elution. Detection wavelength was 241 nm. The degradation products were identified and characterized using UPLC‐MS/TOF studies, and an attempt was made to isolate one of the degradation products by solvent extraction.ResultsThe drug was found to significantly degrade under acidic/alkaline/neutral photolytic, oxidative, and alkaline hydrolytic conditions. Six degradation products (I–VI) were identified through LC‐Q/TOF‐MS studies that were adequately resolved from the drug with the developed UPLC method. All degradation products (I–VI) were ionized in the total ion chromatogram (TIC) in the LC‐MS studies, and these were identified and characterized, and the degradation pathway of the drug was postulated. One of the oxidation products isolated from the degraded drug solution was characterized through differential scanning calorimetry, Fourier‐transform infrared spectroscopy, and nuclear magnetic resonance spectral data.ConclusionsSix degradation products generated from stress degradation studies on azelastine HCl were adequately resolved through LC‐UV/PDA studies followed by method validation. These were successfully identified and characterized through LC‐Q/TOF‐MS studies, and the degradation pathways for the generation of these products from the drug have been postulated.

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Section: Introductionmentioning

confidence: 99%

Method validation and characterization of stress degradation products of azelastine hydrochloride using LC‐UV/PDA and LC‐Q/TOF‐MS studies

Shekhar,

Bali

2024

Rapid Comm Mass Spectrometry

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Collision-induced dissociation pathways of H1-antihistamines by electrospray ionization quadrupole time-of-flight mass spectrometry

Noh

Yoon

et al. 2017

Arch. Pharm. Res.

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Over the past decades, mass spectrometry technologies have been developed to obtain mass accuracies of one ppm or less. Of the newly developed technologies, quadrupole time-of-flight mass spectrometry (Q-TOF-MS) has emerged as being well suited to routine and high-throughput analyses of pharmaceuticals. Dietary supplements and functional foods have frequently been found to be contaminated with pharmaceuticals. In our continuous efforts to develop methodologies to protect public health against adulterated dietary supplements, we have constructed a mass spectral database for 21 H-antihistamines encountered as adulterants by using liquid chromatography-electrospray ionization (LC-ESI)/Q-TOF-MS, and have proposed their possible collision-induced dissociation pathways. This database will be very useful for the rapid and accurate detection of H-antihistamines (known) and their analogues (unknown) illegally added to dietary supplements as well as in other sample matrices.

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Concentration and distribution of polychlorinated biphenyls in rice paddy soils

et al. 2017

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LC–MS/MS monitoring of 22 illegal antihistamine compounds in health food products from the Korean market

Cited by 6 publications

References 12 publications

Method validation and characterization of stress degradation products of azelastine hydrochloride using LC‐UV/PDA and LC‐Q/TOF‐MS studies

Method validation and characterization of stress degradation products of azelastine hydrochloride using LC‐UV/PDA and LC‐Q/TOF‐MS studies

Collision-induced dissociation pathways of H1-antihistamines by electrospray ionization quadrupole time-of-flight mass spectrometry

Concentration and distribution of polychlorinated biphenyls in rice paddy soils

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