JOURNAL 2174


Journal of Chemical Metrology
VOLUME & ISSUE
Available Online: October 09,2021
PAGES
p.1 - 11
DOI ADDRESS
http://doi.org/10.25135/jcm.64.2108-2174
(DOI number will be activated after the manuscript has been available in an issue.)
STATISTICS
Viewed 56 times.
AUTHORS
  • Avani Chokshi
  • Anuradha Gajjar
  • Pooja Bhanushali
  • Pritesh Desai
PDF OF ARTICLE

GRAPHICAL ABSTRACT


ABSTRACT


Dasatinib is a tyrosine kinase inhibitor that is approved and prescribed to patients with chronic myelogenous leukemia and Philadelphia chromosome. Present work reports development of reversed-phase high performance liquid chromatographic method for determination of Dasatinib in human plasma and validation of the developed method according to the guidelines provided by European Medicines Agency (EMA). An RP-HPLC method with UV detection and isocratic elution has been developed and validated for analysis of Dasatinib in human plasma over a range of 5-300 ng/mL. Imatinib was used as an internal standard. Both, the drug and the internal standard were separated on the Inertsil C18 column (150 mm×4.6 mm×0.005 mm) using Ammonium Acetate buffer pH 6.4 and acetonitrile at a ratio of 65:35 as mobile phase. The flow rate was adjusted to 0.7 mL min-1. The detection was performed at 310 nm wavelength. Sample pre-purification was performed through simple protein precipitation using acetonitrile followed by sample collection through centrifugation. The developed method was linear in the range of 5-300 ng/mL with correlation coefficients (r2) of 0.995. The lower limit of quantification for Dasatinib in plasma was 5 ng/mL. The accuracy and precision of the method were well within the acceptable limits of 15% over the linear range. In general, the developed method is efficient and inexpensive. It is very simple from the extraction of drug from the plasma matrix to the isocratic elution of analytes.   From the data, it can be concluded that the developed method is selective, precise and accurate and applicable for the determination of Dasatinib in human plasma samples.

KEYWORDS
  • Dasatinib
  • human plasma
  • liquid chromatography
  • method validation
  • UV

SUPPORTING INFORMATION


Supporting Information
Download File 64-JCM-2108-2174-SI.pdf (261.21 KB)