Aim: Cortisol hair levels can be used to evaluate chronic stress status. In this context, an improved UHPLC–MS/MS assay for the determination of cortisol in hair was developed and validated. Materials & methods: Hair was extracted with methanol for 4 h at 25°C. Chromatographic run time was 5.5 min. The assay was linear in the […]
Aim:Helicobacter pylori infection is a prevalent global bacterial infection that can potentially exaggerate symptoms of other serious infections like SARS-CoV-2 (COVID-19). Methodology: Herein, an efficient, accurate and cost-effective high-performance liquid chromatography-diode array detector method was developed and validated for determination of the novel triple therapy combination of tinidazole (TD), clarithromycin (CLR) and lansoprazole (LAN) in
Aim: Although the fit-for-purpose approach has been proposed for validation procedures and acceptance criteria for biomarker assays, practical biomarker assays to facilitate clinical application and regulatory documents on biomarker assays remain limited. Materials & methods: We assigned six independent laboratories and selected three lysophosphatidylcholines (LPCs): LPC(16:0), LPC(18:0) and LPC(18:1) as model biomarkers. Using LC–MS, the
Dried matrix spots (DMS) has gained the attention of different professionals in different fields, including toxicology. Investigations have been carried out in order to assess the potential of using DMS for the analysis of illicit substances, the main interest of forensic toxicologists. This technique uses minimal volumes of samples and solvents, resulting in simple and
Aim: Investigations have shown that for the antibody–drug conjugate (ADC) belantamab mafodotin, concentrations of the cysteine-conjugated metabolite, Cys-mcMMAF, were overestimated in the presence of the ADC during sample processing when utilizing a historical SPE method. Results: A new assay was developed utilizing an acidic protein precipitation to remove the ADC early in the extraction process,
Aim: Hollow-fiber-based supported liquid membrane was modified utilizing nanostructures such as graphite, graphene oxide or nitrogen-doped graphene oxide, for electro-membrane extraction (EME) of imatinib and sunitinib from biological fluids. By applying these conductive nanostructures, a low-voltage EME device (6.0 V) was fabricated. Materials & methods: A response surface methodology through central composite design was used
Aim: 4-pyridoxic acid (PDA) has been proposed as an endogenous biomarker for renal organic anion transporter 1/3 (OAT1/3) inhibition. Clinical data are needed to support the proposal. Materials & methods: A hydrophilic interaction chromatography (HILIC)–LC/MS/MS assay was developed and characterized to support clinical drug–drug interaction (DDI) studies. Results: A HILIC–LC/MS/MS assay was successfully developed. PDA
Biomarkers are an important drug developmental tool. Assessment of quantitative analytical methods of biomarkers is not included in any regulatory documents in Japan. Use of biomarkers in clinical evaluations and supporting the post-marketing evaluation of drug efficacy and/or adverse reactions requires assessment and full validation of analytical methods for these biomarkers. The Biomarker Analytical Method
Aim: Clinical monitoring of oxcarbazepine (OXC) and its metabolite licarbazepine (MHD) in biological matrix requires a sensitive and validated analytical method. The aim of this study is to develop and validate an optimized ultra performance liquid chromatography–MS/MS based bioanalytical method for the simultaneous estimation of OXC and its metabolite MHD in human plasma, using deuterated
Over the last years, dried blood spot (DBS) sampling has gained significant interest due to development of analytical techniques combined with DBS, the simplicity and low cost of the method. Despite its wide use, DBS sampling can lead to inaccurate results due to the impact of the hematocrit (Hct) on the analysis. Some analytes have