Development and Validation of Amisulpride in Human Plasma by HPLC Coupled with Tandem Mass Spectrometry and its Application to a Pharmacokinetic Study
| Autor: | Ramakotaiah Mogili, Babu Rao Chandu, Kanchanamala Kanala, Balasekhara Reddy Challa, Chandrasekhar Kottapalli Bannoth |
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| Rok vydání: | 2011 |
| Předmět: |
Chromatography
Correlation coefficient Liquid chromatography–tandam mass spectrometry Formic acid Method development Analytical chemistry Pharmaceutical Science Mass spectrometry Tandem mass spectrometry High-performance liquid chromatography chemistry.chemical_compound Method Validation chemistry Pharmacokinetics medicine Amisulpride Methanol Research Article medicine.drug |
| Zdroj: | Scientia Pharmaceutica Volume 79 Issue 3 Pages 583-600 |
| ISSN: | 2218-0532 0036-8709 |
| DOI: | 10.3797/scipharm.1105-12 |
| Popis: | In this study, authors developed a simple, sensitive and specific liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for quantification of Amisulpride in human plasma using Amisulpride-d(5) as an internal standard (IS). Chromatographic separation was performed on Zorbax Bonus-RP C18, 4.6 × 75 mm, 3.5 μm column with an isocratic mobile phase composed of 0.2% formic acid:methanol (35:65 v/v), at a flow-rate of 0.5 mL/min. Amisulpride, Amisulpride-d(5) was detected at m/z 370.1→242.1 and 375.1→242.1. The drug and the IS were extracted by a liquid-liquid extraction method. The method was validated over a linear concentration range of 2.0-2500.0 ng/mL for Amisulpride with a correlation coefficient of (r(2)) ≥ 0.9982. This method demonstrated intra- and inter-day precision within 0.9 to 1.7 and 1.5 to 2.8 % and intra- and inter-day accuracy within 98.3 to 101.5 and 96.0 to 101.0 % for Amisulpride. Amisulpride was found to be stable at 3 freeze-thaw cycles, bench top and auto sampler stability studies. The developed method was successfully applied to a pharmacokinetic study. |
| Databáze: | OpenAIRE |
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