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Chromatographic Separation and Quantification of Nine Nitrosamine Genotoxic Impurities in a Single Method in Nebivolol Tablet by Using Validated Ultra-Sensitive Liquid Chromatography: Mass Spectrometry Analytical Method.
J Chromatogr Sci
December 2024
Analytical Research Laboratory, Cadila Pharmaceuticals Ltd., Dholka, Ahmedabad 382225, India.
N-nitrosamine impurities have been detected in a vast variety of drug substances and drug products, showing concern for regulatory aspects. To meet the regulatory requirement for the concerned impurity, a sensitive analytical method capable of quantifying these impurities at a lower level with accuracy and precision is required. This article focuses on the development and validation of an analytical method for the simultaneous detection of nine nitrosamine impurities in a single method for nebivolol drug product using liquid chromatography-mass spectrometry/mass spectrometry-atmospheric pressure chemical ionization (LC-MS/MS-APCI).
View Article and Find Full Text PDFSimultaneous determination of three β-Lactam/β-lactamase inhibitor combinations in critically ill patients by UPLC-MS/MS.
J Chromatogr B Analyt Technol Biomed Life Sci
December 2024
Department of Pharmacy, China-Japan Friendship Hospital, Beijing 100029, China. Electronic address:
β-Lactam/β-lactamase inhibitors (BL/BLIs) are widely used in critically ill patients. Recent research has shown the importance of therapeutic drug monitoring (TDM) of BLs, but few studies have highlighted the importance of detecting BLIs in critically ill patients. In our laboratory, we have developed and validated a simple and robust method for the determination of ceftazidime, cefoperazone, piperacillin, avibactam, sulbactam and tazobactam in human plasma by ultra-high performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS).
View Article and Find Full Text PDF[Determination of 12 halogenated organic pollutants in edible fish by ultra performance liquid chromatography-high resolution mass spectrometry combined with ultrasound-assisted extraction and gel permeation chromatography purification].
Se Pu
January 2025
Research Center for Eco-Environmental Engineering, Dongguan University of Technology, Dongguan 523808, China.
Halogenated organic pollutants (HOPs) have attracted considerable attention owing to their persistence, bioaccumulation, and toxicity. The development of methods to detect HOPs in fish is challenging owing to the compositional complexity of fish matrices, which contain high levels of lipids and relatively low concentrations of HOPs. In addition, the lipophilicity of most HOPs renders their extraction difficult.
View Article and Find Full Text PDFStability-Indicating Liquid Chromatographic Method Development for the Simultaneous Determination of Amitriptyline Hydrochloride and Propranolol Hydrochloride in Tablet Dosage Form.
J Chromatogr Sci
December 2024
Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Mysuru 570 015, Karnataka, India.
The combination of the tricyclic antidepressant amitriptyline hydrochloride (AMH) and the non-selective beta-adrenergic blocker propranolol hydrochloride (PPH) is used for migraine prophylaxis. Higher doses of AMH trigger cardiac arrhythmias, anxiety, tachycardia, convulsions, hyperglycemia and anticholinergic side effects. The combined dosage formulation of AMH and PPH leads to drug-drug interactions; causes sedation, xerostomia, dysuria, insomnia and bradycardia; and results in patient non-compliance.
View Article and Find Full Text PDFPreparation of a 1,1'-Binaphthyl-based Chiral Polyimine Macrocycle Bonded Chiral Stationary Phase by Thiol-ene Click Reaction and Its Enantioseparation Performance in High-Performance Liquid Chromatography.
J Sep Sci
December 2024
College of Chemistry and Chemical Engineering, Yunnan Normal University, Kunming, China.
Chiral macrocycles have emerged as attractive media for chromatographic enantioseparation due to their excellent host-guest recognition properties. In this study, a new chiral stationary phase (CSP) based on 1,1'-binaphthyl chiral polyimine macrocycle (CPM) was reported. The CPM was synthesized by one-step aldehyde-amine condensation of (S)-2,2'-dihydroxy-[1,1'-binaphthalene]-3,3'-dicarboxaldehyde with 1,2-phenylenediamine and bonded on thiolated silica via the thiol-ene click reaction to afford the CSP.
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