AN LC-ESI-MS/MS METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTIFICATION OF INFIGRATINIB IN BIOLOGICAL MATRICES

Q2 Pharmacology, Toxicology and Pharmaceutics

International Journal of Applied Pharmaceutics Pub Date : 2024-01-07 DOI:10.22159/ijap.2024v16i1.49476

Phani Kumar Sunkara, Sreedhara Chaganty, K. Ramakrishna

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引用次数: 0

Abstract

Objective: The study was aimed to develop a precise and simple liquid chromatographic electrospray ionization tandem mass spectrometric (LC-ESI-MSMS) technique is essential for the quantification of Infigratinib in biological matrices. Methods: Chromatographic resolution was attained with PhenominexC18 (50 mm×2.6 mm, 3 µm) stationary column and a mobile solvent composition of 0.1% HCOOH, methyl alcohol and acetonitrile in the proportion of 10:10:80. Chromatograms were resolved by an isocratic separation with a flowing rate of 0.50 ml/min at 40 °C. Results: Quantitation was executed by monitoring the transitions of m/z. 560.19/189.13 for Infigratinib and 494.5→394.5 for Imatinib internal standard in multiple reaction monitoring. The standard curve regression line was y = 0.0016x+0.0062 and the correction coefficient (r2) was 0.9994. The % CV outcomes for matrix effect at Lower-QC and Higher-QC were 4.95% and 3.61% respectively. The percentage average recoveries for Infigratinib in Higher-QC (900ng/ml), MQC (600ng/ml) and Lower-QC (3ng/ml) were 93.27%, 94.69% and 97.24% respectively. The intra and interday precisions of analytical procedure was estimated by assessing the %CV outcomes and were in between 1.88 to 5.93% for the QC samples. Conclusion: The developed procedure can be useful for the assessment of Infigratinib in biological matrices in quality control, forensic and bioavailability studies.

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用于生物基质中英夫瑞替尼定量的 LC-ESI-MS/MS 方法开发与验证

研究目的本研究旨在开发一种精确简便的液相色谱电喷雾串联质谱（LC-ESI-MSMS）技术，该技术对于生物基质中英夫瑞替尼的定量至关重要：采用 PhenominexC18（50 mm×2.6 mm，3 µm）固定相色谱柱，以 0.1% HCOOH、甲醇和乙腈按 10:10:80 的比例组成的流动溶剂进行色谱分析。色谱图在 40 °C 下以 0.50 ml/min 的流速进行等度分离：结果：通过监测 m/z.在多反应监测中，英夫瑞替尼的转化率为 560.19/189.13，伊马替尼内标物的转化率为 494.5→394.5。标准曲线回归线为 y = 0.0016x+0.0062，校正系数（r2）为 0.9994。基质效应在低质控和高质控下的 CV 结果分别为 4.95% 和 3.61%。英夫瑞替尼在高级质控（900ng/ml）、中级质控（600ng/ml）和低级质控（3ng/ml）下的平均回收率分别为 93.27%、94.69% 和 97.24%。分析程序的日内和日间精确度是通过评估%CV结果来估算的，质控样本的精确度在1.88%到5.93%之间：结论：所开发的程序可用于生物基质中英夫瑞替尼的质量控制、法医鉴定和生物利用度研究。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

International Journal of Applied Pharmaceutics Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

CiteScore

1.40

自引率

0.00%

发文量

219

期刊介绍： International Journal of Applied Pharmaceutics (Int J App Pharm) is a peer-reviewed, bimonthly (onward March 2017) open access journal devoted to the excellence and research in the pure pharmaceutics. This Journal publishes original research work that contributes significantly to further the scientific knowledge in conventional dosage forms, formulation development and characterization, controlled and novel drug delivery, biopharmaceutics, pharmacokinetics, molecular drug design, polymer-based drug delivery, nanotechnology, nanocarrier based drug delivery, novel routes and modes of delivery; responsive delivery systems, prodrug design, development and characterization of the targeted drug delivery systems, ligand carrier interactions etc. However, the other areas which are related to the pharmaceutics are also entertained includes physical pharmacy and API (active pharmaceutical ingredients) analysis. The Journal publishes original research work either as a Original Article or as a Short Communication. Review Articles on a current topic in the said fields are also considered for publication in the Journal.