A comprehensive evaluation of a bioanalytical technique for Encorafenib and Cetuximab combination Cancer therapy by LC-MS/MS and their pharmacokinetics in plasma.

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Tác giả: Anoop Bodapati, Sudha Divya Madhuri Kallam, Bangaraiah Pagala

Ngôn ngữ: eng

Ký hiệu phân loại: 942.0164 *England and Wales

Thông tin xuất bản: Netherlands : Journal of chromatography. B, Analytical technologies in the biomedical and life sciences , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 643511

The FDA authorized Encorafenib on April 8, 2020, taken along with cetuximab to treat patients (adults) with advanced metastatic colo-rectal cancers, who have a mutation of BRAF-V600E and have previously undergone therapy. No documented techniques for the simultaneous quantitation of Encorafenib and Cetuximab using LC-MS/MS was available, so a reliable, fast, and unique method was developed and validated. Method development involved optimizing chromatographic and mass spectrometric conditions to achieve high sensitivity and specificity. The method was validated per FDA guidelines, evaluating parameters such as linearity, precision, accuracy, recovery, and stability under various conditions. Mass ion pairs were tracked using multiple reaction monitoring (MRM) in positive polarity mode and the precursor to daughter ion transition m/z values for Encorafenib, Cetuximab(peptide), and Tofacitinib (internal reference) are 540.15 → 369.85, 643.34 → 653.31, and 313.17 → 221.05, respectively. The calibration curves demonstrated excellent linearity over 3.75-150 ng/mL ranges for Encorafenib and 0.25-10 ng/mL for Cetuximab. The MS
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