Quantification of Alectinib in spiked rabbit plasma using liquid chromatography- electro spray ionization-tandem mass spectrophotometry: An application to pharmacokinetic study

Q2 Chemistry Current Chemistry Letters Pub Date : 2023-01-01 DOI:10.5267/j.ccl.2023.1.002

H. Kumar, S. Acharyya, P. Mondal, P. Patra, Satyabrata Sahu

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Abstract

The current technique was developed to estimate the amount of alectinib present in spiked rabbit plasma using liquid chromatographic mass spectrometry. The liquid-liquid extraction method was used, and chromatographic separation was carried out on a C18 (4.6mm id x 50mm) analytical column with a mobile phase consisting of acetonitrile and water with 0.1% formic acid at a volume ratio of 75:25. Alectinib's product m/z +483.2 (parent) 396.1 (product) and the internal standard m/z +447.5 (parent) 380.3 (product) were both obtained using positive ion mode. The calibration curve was linear from 0.5 to 600 ng/ml. The percentage extraction recovery (98.15% → 98.86%), demonstrated excellent matrix and analyte selectivity (% interference = 0), and satisfactory stability study results in all types (% nominal 94.94% → 99.63%). The intra and interday accuracy with % nominal 97 → 98.8%, precision % CV ≤ 2% in all quality control levels. The rabbit model's pharmacokinetic parameters were examined, and alectinib's area under the curve (AUC 0—∞) was 4269 ± 8.13 hr.ng/ml. The half-life of elimination (t1/2) is 8.52 ± 6.66 hours. The currently established approach was used in rabbit blood samples for pharmacokinetic investigations of commercial formulations since it was thought to be a novel, verified bioanalytical method based on experimental results.

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液相色谱-电喷雾电离-串联质谱法定量家兔血浆中阿勒替尼的药代动力学研究

目前的技术是利用液相色谱-质谱法估计加标兔血浆中存在的阿勒替尼的量。采用液液萃取法，色谱分离采用C18 (4.6mm id x 50mm)分析柱，流动相为乙腈-水- 0.1%甲酸，体积比为75:25。用正离子模式得到Alectinib的产物m/z +483.2(母体)396.1(产物)和内标m/z +447.5(母体)380.3(产物)。校准曲线在0.5 ~ 600 ng/ml范围内呈线性。萃取回收率(98.15%→98.86%)，对基质和分析物具有良好的选择性(%干扰= 0)，稳定性研究结果满意(%标称94.94%→99.63%)。在所有质量控制水平内、日间准确度为%标称97→98.8%，精密度% CV≤2%。测定兔模型药动学参数，阿勒替尼曲线下面积(AUC 0 -∞)为4269±8.13 hr.ng/ml。消除半衰期(t1/2)为8.52±6.66小时。目前建立的方法被用于兔血液样本的药代动力学研究，因为它被认为是一种基于实验结果的新颖的、经过验证的生物分析方法。

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来源期刊

Current Chemistry Letters Chemistry-Chemistry (all)

CiteScore

4.90

自引率

0.00%

发文量

审稿时长

20 weeks

期刊介绍： The "Current Chemistry Letters" is a peer-reviewed international journal which aims to publish all the current and outstanding research articles, reviews and letters in chemistry including analytical chemistry, green chemistry, inorganic chemistry, organic chemistry, physical chemistry, etc. This journal is dedicated to serve all academic and industrial researchers and scientists who are expert in all major advances in chemistry research. The journal aims to provide the most complete and reliable source of information on current developments in these fields. The emphasis will be on publishing quality articles rapidly and openly available to researchers worldwide. Please note readers are free to read, download, copy, distribute, print, search, or link to the full texts of articles published on this journal. Current Chemistry Letters is an open access journal, which provides instant access to the full text of research papers without any need for a subscription to the journal where the papers are published. Therefore, anyone has the opportunity to copy, use, redistribute, transmit/display the work publicly and to distribute derivative works, in any sort of digital form for any responsible purpose, subject to appropriate attribution of authorship. Authors who publish their articles may also maintain the copyright of their articles.