TY  - JOUR
T1  - A novel analytical method for Dasatinib Tablet by liquid chromatography in the presence of Triton X-100 and biorelevant media in dissolution medium
AU  - Pınarbaslı, Onur
AU  - Ozbay, Tolga
AU  - Gurbetoglu, Gulistan Pelin
AU  - Sarracoglu, Nagehan
AU  - Aybey, Asuman
PY  - 2025
DA  - July
Y2  - 2024
DO  - 10.12991/jrespharm.1734636
JF  - Journal of Research in Pharmacy
JO  - J. Res. Pharm.
PB  - Marmara University
WT  - DergiPark
SN  - 2630-6344
SP  - 1664
EP  - 1674
VL  - 29
IS  - 4
LA  - en
AB  - The purpose of this study is to develop and validate a rapid and simple HPLC method for determining the dissolution of Dasatinib in tablet form. The Dasatinib was separated from the dissolution medium containing Triton X-100 and also from biorelevant dissolution media having a complex matrix using high-performance liquid chromatography (HPLC-Shimadzu Prominence 20A) with a reverse-phase C18 column (particle size: 5μm; dimension: 4.6 mm X 250 mm). The column temperature was maintained at 30°C. The mobile phase consisted of a mixture of ammonium acetate buffer pH 5.0, acetonitrile, and water. The flow rate was set to 1.0 mL/min, and detection was performed at a wavelength of 230 nm. The method was validated for specificity, linearity and range, accuracy, precision, and robustness in accordance with ICH requirements. The retention time of Dasatinib was determined to be 4.1 minutes. Concentration range of the study was 7 μg/ml to 168 μg/ml, and the calibration was linear (r2= 1.000). The developed method allows for easy detection of the percent drug release in Dasatinib tablets in pH 4.0 acetate buffer containing 1.0% Triton X-100 medium, which is the dissolution medium specified by the Food and Drug Administration and in biorelevant dissolution media (FaSSIF, FeSSIF, FaSSGF) showing in vitro-in vivo correlation (IVIC). The RP-HPLC technique used is stable, simple, accurate, and completely validated for the release of Dasatinib from tablet dosage forms.
KW  - Dasatinib
KW  - dissolution method
KW  - drug release %
KW  - RP-HPLC
KW  - tablet
KW  - validation
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UR  - https://doi.org/10.12991/jrespharm.1734636
L1  - https://dergipark.org.tr/en/download/article-file/5022164
ER  -