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Journal of Bioequivalence & Bioavailability

Tawfiq Arafate

Jordan Center for Pharmaceutical Research, Amman, Jordan

  • Research Article   
    Determination of Fingolimod in Whole Blood by LC-MS/MS: Application to Bioequivalence Study
    Author(s): Ahmed Abu-Awwad*, Tawfiq Arafate, Basil Arafat, Asaad Shahin, Hadil Alotaibi and Mona Bustami

    A new bioanalytical liquid chromatography tandem mass spectrometric method has developed and validated for a clinical determination of fingolimod hydrochloride in whole blood. The method has applied in bioequivalence study following parallel open-label design, randomized single dose, and two treatments by healthy adult male subjects under fasting conditions. Fingolimod with labeled Internal Standard (IS; Fingolimod-D4) was extracted from human blood by liquid-liquid extraction and separated chromatographically from their matrix by Fortis UniverSil Cyano column. The established method was validated over calibration dynamic range of 12-1200 pg/ml for spiked blood. In single period, each subject of 42 healthy volunteer was received a single dose of 0.5 mg fingolimod hydrochloride capsule of either the test or reference product. The pharmacokinetic parameters of C.. View more»

    DOI: 10.35248/0975-0851.22.14.469

    Abstract HTML PDF