Determination of Clorsulon and its related substances in commercial bulk drug substance batches by a rapid ion-pair UPLC method.

Autor: Zhao D; Global Pharmaceutical Technical Support (GPTS), Boehringer Ingelheim Animal Health USA Inc., North Brunswick, NJ 08902, USA. Electronic address: Daoli.Zhao@boehringer-ingelheim.com., Rustum AM; Global Pharmaceutical Technical Support (GPTS), Boehringer Ingelheim Animal Health USA Inc., North Brunswick, NJ 08902, USA.
Jazyk: angličtina
Zdroj: Journal of pharmaceutical and biomedical analysis [J Pharm Biomed Anal] 2024 Feb 15; Vol. 239, pp. 115896. Date of Electronic Publication: 2023 Dec 02.
DOI: 10.1016/j.jpba.2023.115896
Abstrakt: Clorsulon is a potent anthelmintic agent and is widely used for the treatment and control of parasites including adult liver flukes in cattle and sheep. A rapid ion-paired reversed phase ultraperformance liquid chromatography (IP-UPLC) method has been developed and validated for determination of Clorsulon and its related substances in bulk drug substance batches of Clorsulon with a short octadecyl column. Analytes were eluted by a gradient elution on a Acquity UPLC® BEH C18 column (50 mm × 2.1 mm i.d., 1.7 µm particle size). Column temperature was maintained at 55 °C and all analytes were monitored by UV detection at 268 nm. Mobile phase-A constitutes 3 mM tetrabutylammonium hydroxide in H 2 O and mobile phase-B constitutes acetonitrile/methanol (50/50, v/v), respectively. All analytes of interest were adequately separated within 5 min. The analytes were quantitated against an external reference standard of Clorsulon. The chemical structures of degradation products of Clorsulon were proposed based on two-dimensional UPLC-MS data. The IP-UPLC method has been successfully validated and demonstrated to be accurate, sensitive, robust, and specific.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2023 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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