Academic Journal
Sensitive and specific LC-ESI-MS/MS method for determination of ZYDPLA1, a novel long-acting dipeptidyl peptidase 4 inhibitor in rat plasma: An application for toxicokinetic study in rats.
| Title: | Sensitive and specific LC-ESI-MS/MS method for determination of ZYDPLA1, a novel long-acting dipeptidyl peptidase 4 inhibitor in rat plasma: An application for toxicokinetic study in rats. |
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| Authors: | Giri P; Department of Drug Metabolism & Pharmacokinetics, Zydus Research Centre, A Division of Cadila Healthcare Ltd., Ahmedabad, India., Patel N; Department of Drug Metabolism & Pharmacokinetics, Zydus Research Centre, A Division of Cadila Healthcare Ltd., Ahmedabad, India., Patel B; Department of Drug Metabolism & Pharmacokinetics, Zydus Research Centre, A Division of Cadila Healthcare Ltd., Ahmedabad, India., Patel H; Department of Drug Metabolism & Pharmacokinetics, Zydus Research Centre, A Division of Cadila Healthcare Ltd., Ahmedabad, India., Bahekar R; Department of Medicinal Chemistry, Zydus Research Centre, A Division of Cadila Healthcare Ltd., Ahmedabad, India., Srinivas NR; Department of Drug Metabolism & Pharmacokinetics, Zydus Research Centre, A Division of Cadila Healthcare Ltd., Ahmedabad, India., Patel PR; Department of Drug Metabolism & Pharmacokinetics, Zydus Research Centre, A Division of Cadila Healthcare Ltd., Ahmedabad, India.; Department of Medicinal Chemistry, Zydus Research Centre, A Division of Cadila Healthcare Ltd., Ahmedabad, India., Desai R; Department of Medicinal Chemistry, Zydus Research Centre, A Division of Cadila Healthcare Ltd., Ahmedabad, India. |
| Source: | Biomedical chromatography : BMC [Biomed Chromatogr] 2017 Nov; Vol. 31 (11). Date of Electronic Publication: 2017 May 29. |
| Publication Type: | Journal Article |
| Language: | English |
| Journal Info: | Publisher: Wiley Country of Publication: England NLM ID: 8610241 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1099-0801 (Electronic) Linking ISSN: 02693879 NLM ISO Abbreviation: Biomed Chromatogr Subsets: MEDLINE |
| Imprint Name(s): | Publication: 1990- : Chichester : Wiley Original Publication: London : Heyden & Son, c1986-1990 |
| MeSH Terms: | Chromatography, Liquid/*methods , Dipeptidyl-Peptidase IV Inhibitors/*blood , Dipeptidyl-Peptidase IV Inhibitors/*toxicity , Spectrometry, Mass, Electrospray Ionization/*methods, Dipeptidyl-Peptidase IV Inhibitors/chemistry ; Dipeptidyl-Peptidase IV Inhibitors/pharmacokinetics ; Tandem Mass Spectrometry/methods ; Animals ; Limit of Detection ; Linear Models ; Male ; Rats ; Rats, Wistar ; Reproducibility of Results |
| Abstract: | A rapid and highly specific assay was developed and validated for the estimation of ZYDPLA1 in rat plasma using liquid chromatography coupled to tandem mass spectrometry with positive electrospray ionization. Method validation comprised of parameters such as specificity, matrix effect, precision, accuracy, recovery, stability, etc. The assay procedure involved a simple protein precipitation of ZYDPLA1 and alprazolam (internal standard) from rat plasma using acetonitrile. Chromatographic separation was achieved with a gradient mobile phase comprising: (A) 0.2% ammonia in purified water; (B) 0.1% formic acid in isopropyl alcohol/methanol (1: 1 v/v); and (C) acetonitrile at a flow rate of 1 mL/min on an ACE-5, C18 (4.6 × 50 mm) column with a run time of 5.5 min. The quantitation of ZYDPLA1 was achieved by the summation of four multiple reaction mode transitions (m/z 399.7 → 383.0, 399.7 → 276.10, 399.7 → 153.20 and 399.7 → 127.20), while that of the internal standard was by a single multiple reaction mode transition (m/z 309.10 → 281.00). The lower limit of quantitation achieved was 0.01 μg/mL and the method showed linearity from 0.01 to 25 μg/mL. The intra- and inter-day precision (%CV) of the quality control samples was within 8.81% and accuracy was ±10% of nominal values. This novel method was applied for evaluation of toxicokinetics of ZYDLA1 in rats. (Copyright © 2017 John Wiley & Sons, Ltd.) |
| Contributed Indexing: | Keywords: DPP-4 inhibitor; LC-ESI-MS/MS; Toxicokinetics; ZYDPLA1; method validations; rat plasmasss |
| Substance Nomenclature: | 0 (Dipeptidyl-Peptidase IV Inhibitors) |
| Entry Date(s): | Date Created: 20170404 Date Completed: 20171024 Latest Revision: 20171024 |
| Update Code: | 20260130 |
| DOI: | 10.1002/bmc.3984 |
| PMID: | 28370279 |
| Database: | MEDLINE |
| ISSN: | 1099-0801 |
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| DOI: | 10.1002/bmc.3984 |