Validated LC-MS/MS Method for Simultaneous Quantitation of SAFit-1 and SAFit-2 in Mice Plasma: Application to a Pharmacokinetic Study
| Autor: | Neeraj Kumar Saini, Suresh P. Sulochana, Mahanandeesha S. Hallur, Ramesh Mullangi, Sridharan Rajagopal, Swapan Kumar Samanta, Anup H.A. Siddesh, Bhavesh Babulal Gabani, Vinay Kiran |
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| Rok vydání: | 2020 |
| Předmět: |
Male
Resolution (mass spectrometry) Formic acid Chemistry Pharmaceutical Administration Oral Mice plasma Tandem mass spectrometry 01 natural sciences Sensitivity and Specificity Tacrolimus Binding Proteins 03 medical and health sciences chemistry.chemical_compound Mice 0302 clinical medicine Column chromatography Pharmacokinetics Tandem Mass Spectrometry Drug Discovery Lc ms ms Animals Chromatography High Pressure Liquid Chromatography 010405 organic chemistry General Medicine Antidepressive Agents 0104 chemical sciences chemistry 030220 oncology & carcinogenesis Extraction methods |
| Zdroj: | Drug research. 70(7) |
| ISSN: | 2194-9387 |
| Popis: | SAFit-1 and SAFit-2 are selective FKBP51 (FK506-binding protein 51) ligands. In this paper, we present the development and validation data of an LC-MS/MS method for the simultaneous quantitation of SAFit-1 and SAFit-2 in mice plasma as per FDA regulatory guideline. SAFit-1 and SAFit-2 along with internal standard were extracted from mice plasma using liquid-liquid extraction method. Chromatographic resolution of SAFit-1, SAFit-2 and the internal standard (warfarin) was achieved on an X-Terra phenyl column using 0.2% formic acid:acetonitrile (20:80, v/v) as an eluent, which was delivered at a flow-rate of 0.9 mL/min. The MS/MS ion transitions monitored were m/z 748.4→420.4, 803.7→384.3 and 309.2 →163.2 for SAFit-1, SAFit-2 and the internal standard, respectively. The linearity range was 2.45–2446 ng/mL for both SAFit-1 and SAFit-2. The intra- and inter-day accuracy and intra- and inter-day precision were in the range of 0.90–1.07 and 2.38–10.8%, respectively for SAFit-1; 0.97–1.15 and 0.23–12.5%, respectively for SAFit-2. Both SAFit-1 and SAFit-2 were found to be stable in stability studies (up to three freeze-thaw cycles and for long-term at −80°C for 30 days) and processed (bench-top for 3 h and in in-injector for 16 h) samples. The application of the validated method was shown in a pharmacokinetic study in mice. |
| Databáze: | OpenAIRE |
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