BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF ASCIMINIB ANTICANCER DRUG IN BIOLOGICAL MATRICES BY LC–ESI-MS/MS

MANTRAVADI ANUSHA; KUMAR SHIVA GUBBIYAPPA

doi:10.22159/ijap.2024v16i6.52154

Authors

MANTRAVADI ANUSHA Department of Pharmaceutical Analysis, GITAM School of Pharmacy, GITAM Deemed to be Univeristy, Rudraram, Patancheru, Telangana, India https://orcid.org/0009-0008-8533-7222
KUMAR SHIVA GUBBIYAPPA Department of Pharmaceutical Analysis, GITAM School of Pharmacy, GITAM Deemed to be Univeristy, Rudraram, Patancheru, Telangana, India

DOI:

https://doi.org/10.22159/ijap.2024v16i6.52154

Keywords:

Asciminib, Cancer, FDA, Sensitivity, Precision, Accuracy

Abstract

Objective: A unique liquid chromatography-mass spectrometry technique is essential for determining the concentration of asciminib in biological matrices, and its development is of the utmost importance.

Methods: The samples that were processed were separated using a Reversed Phase-Phenomenex (100 mm x 4.6 mm, 5 µm) C18 analytical column. The column was equipped with an isocratic moveable phase that consisted of 0.1% (v/v) HCOOH and acetonitrile at a ratio of 18:82% (v/v). The flow rate of the phase was 0.70 mL/min. For asciminib, the multiple reaction monitoring mode was used at m/z 450.23/257.3, while for canagliflozin, it was used at m/z 445.13/267.31.

Results: With a correlation coefficient of 0.9998, the method was linear for asciminib throughout the concentration range of 1.0-2100.00 ng/mL. Each day's accuracy percentage relative standard deviation was within 5.74%. For analytes at the low-quality control level, the mean matrix factors ranged from 96.34 to 104.85% with a % Coefficient of Variance (CV) of 4.21; at the high-quality control level, the range was from 94.62 to 103.88% with a %CV of 3.67.

Conclusion: The method that has been developed has the potential to be used to examine the pharmacokinetics and toxicokinetics of asciminib in various biological samples for both forensic and clinical purposes.

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