Development and validation of sensitive LC–MS/MS method for the quantification of SUVN-502 and its metabolite and its application for first in human pharmacokinetic study
| Autor: | Hanumanth Rao Pantangi, Rajesh Kumar Boggavarapu, Naga Surya Prakash Padala, Lakshmiprasanna Rayapati, Devender Reddy Ajjala, Raghupathi Aleti, Ramakrishna Nirogi |
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| Rok vydání: | 2017 |
| Předmět: |
Accuracy and precision
Indoles Metabolite Clinical Biochemistry Analytical chemistry Pharmaceutical Science 030226 pharmacology & pharmacy Piperazines Analytical Chemistry 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Pharmacokinetics Tandem Mass Spectrometry Drug Discovery Humans Spectroscopy Chromatography Elution Solid Phase Extraction Selected reaction monitoring Extraction (chemistry) Reproducibility of Results Standard curve chemistry Ammonium acetate 030217 neurology & neurosurgery Chromatography Liquid |
| Zdroj: | Journal of Pharmaceutical and Biomedical Analysis. 145:423-430 |
| ISSN: | 0731-7085 |
| Popis: | A sensitive and rapid LC-MS/MS method was developed and validated for the quantification of SUVN-502 and M1 of SUVN-502, a 5-HT6 receptor antagonist for the treatment of dementia associated with Alzheimer's disease. Following solid-phase extraction, SUVN-502 and M1 of SUVN-502 and IS were eluted with 10mM ammonium acetate (pH 4.0) and acetonitrile using a rapid gradient program on reverse phase column. Multiple reaction monitoring mode was used to monitor the respective transitions of m/z 478.2→377.7 for SUVN-502 and m/z 464.1→377.7 for M1 of SUVN-502. The assay exhibited a linear dynamic range of 10-10000pg/mL for SUVN-502 and 20-20000pg/mL for M1 of SUVN-502 in human plasma. Acceptable precision and accuracy were obtained for concentrations over the standard curve range. The within batch accuracy and precision were within acceptable limits. All the other validation parameters were within the acceptable limits. The validated method was applied to analyze human plasma samples obtained from a human pharmacokinetic study consisting single and multiple ascending doses. |
| Databáze: | OpenAIRE |
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