Title | LC-MS/MS method development for quantification of busulfan in human plasma and its application in pharmacokinetic study. |
Publication Type | Journal Article |
Year of Publication | 2016 |
Authors | Nadella TRamarao, Suryadevara V, Lankapalli SReddyvalla, Mandava VBasaveswar, Bandarupalli D |
Journal | J Pharm Biomed Anal |
Volume | 120 |
Pagination | 168-74 |
Date Published | 2016 Feb 20 |
ISSN | 1873-264X |
Keywords | Administration, Oral, Busulfan, Chromatography, Liquid, Humans, Male, Mass Spectrometry, Tandem Mass Spectrometry |
Abstract | A simple, rapid, specific and precise liquid chromatography-tandem mass spectrophotometric (LC-MS/MS) method was developed and validated for quantification of busulfan, in human plasma. busulfan d8 was used as internal standard, added to plasma sample prior to extraction using acetonitrile as a precipitating agent. Chromatographic separation was achieved on phenomenex kinetex C18 column (50mm×2.1mm, 2.6μm) with acteonitrile: 10mM ammonium formate buffer (80:20v/v) as an isocratic mobile phase with a flow rate of 0.5mLmin(-1). Quantitation was performed by transition of 264.1→151.1 (m/z) for busulfan and 272.1→159.1 (m/z) for busulfan d8. The lower limit of quantitation was 0.2ngmL(-1) with a 100μL plasma sample. The concentrations of nine working standards showed linearity between 0.2 and 100ngmL(-1) (r(2)≥0.9986). Chromatographic separation was achieved within 2.0min. The average extraction recoveries of 3quality control concentrations were 92.52% for busulfan and 90.75% for busulfan d8. The coefficient of variation was ≤15% for intra- and inter-batch assays. The developed method was successfully applied for the determination of Busulfan pharmacokinetics after oral administration. |
DOI | 10.1016/j.jpba.2015.12.024 |
Alternate Journal | J Pharm Biomed Anal |
PubMed ID | 26736033 |
Submitted by kej2006 on June 6, 2018 - 4:11pm