Quantification of Palbociclib in Spiked Human Plasma Using Liquid Chromatography- Electro Spray Ionization-tandem Mass Spectrophotometry- an Application to Pharmacokinetic Study

    Published on:February 2022
    Journal of Young Pharmacists, 2022; 14(1):82-88
    Original Article | doi:10.5530/jyp.2022.14.16
    Authors:

    Badikela Ramakrishna1, Sumanta Mondal1,*, Prasenjit Mondal2

    1Department of Pharmaceutical chemistry, GITAM Institute of pharmacy, GITAM Deemed to be University, Gandhi Nagar, Rushikonda, Visakhapatnam, Andhra Pradesh, INDIA.

    2Vaageswari Institute of Pharmaceutical Scineces, Karimnagar, Telangana, INDIA.

    Abstract:

    Objectives: The present method was developed for the estimation of palbociclib in spiked human plasma using Liquid chromatographic mass spectroscopy. Methods: The liquid-liquid extraction method was adopted and chromatographic separation was performed on a waters symmetry shield, C18 (4.6mm id x 50 mm) analytical column using (methanol: ultrapure water, pH 4.2 in the volume ratio of 60:40) as mobile phase. Positive ion mode was selected to obtain the product m/z +447.5 (parent) → 380.3 (product) for palbociclib and m/z +434.5 (parent) → 322.7 (product) for internal standard. Results: Calibration curve was linear over the range of 3-600 ng/ml. The intra and interday accuracy with % nominal 95 → 98.4 %, precision %CV ≤ 2% in all quality control levels, The percentage extraction recovery (96.15 % → 98.34 %), demonstrated excellent matrix and analyte selectivity (% interference = 0), and satisfactory stability study results in all types (% nominal 93.91 % → 99.58 %). The pharmacokinetic parameters was studied in the rabbit model, and the area under the curve (AUC0-∞) for palbociclib was 2632 ± 6.98 hr.ng/ml. The elimination half-life (t1/2) is 11.3 ± 5.3 hr. Conclusion: Based on the experimental findings the current developed method was considered a novel validated bioanalytical method, and applied in rabbit blood samples for pharmacokinetic studies of marketed formulations.

    Key words: Palbociclib, Bioanalytical, Pharmacokinetic study, LCMS/MS, method development.

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