A novel analytical method for Dasatinib Tablet by liquid chromatography in the presence of Triton X-100 and biorelevant media in dissolution medium

Abstract

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.

Keywords

• Dasatinib
• dissolution method
• drug release %
• RP-HPLC
• tablet
• validation

References

1. [1] Alharbi HM, Alqahtani T, Batubara A, Alshaer A, Alqurashi B, Bahwairth L, Khawaji H, Almohammadi M. Enhancing the Dissolution of Oral Dasatinib Tablets Using Zein–Hydroxypropyl Methylcellulose Solid Dispersions. Int J Pharm Res Allied Sci. 2023; 12(1): 139-148. https://doi.org/10.51847/crBI2n6KLG.
2. [2] Sahoo CK, Sudhakar M, Bhanja S, Panigrahy UP, Panda KC. Development and evaluation of immediate release tablets of dasatinib using sodium starch glycolate as super disintegrants. Innoriginal: Int J Sci. 2017; 4(1).
3. [3] Jeslin D, Prema S, Ismail Y, Panigrahy UP, Vijayamma G, Chandan RS, Deepthi KL, Kumar JP. Analytical method validation of dissolution method for the determination of % drug release in dasatinib tablets 20mg, 50mg and 70mg by HPLC. J Pharm Negat Res. 2022; 13(7): 2722-2732. https://doi.org/10.47750/pnr.2022.13.S07.364
4. [4] Lakka NS, Kuppan C, Srinivas KS, Yarra R. Separation and characterization of new forced degradation products of Dasatinib in tablet dosage formulation using LC–MS and stability-indicating HPLC methods. Chromatographia. 2020; 83(8): 947-962. https://doi.org/10.1007/s10337-020-03920-0.
5. [5] Tsume Y, Takeuchi S, Matsui K, Amidon GE, Amidon GL. In vitro dissolution methodology, mini-Gastrointestinal Simulator (mGIS), predicts better in vivo dissolution of a weak base drug, dasatinib. European Journal of Pharmaceutical Sciences. 2015; 76: 203-212. https://doi.org/10.1016/j.ejps.2015.05.013.
6. [6] Fish WP, Young J, Shah P, Gao Z. The use of experimental design principles in dissolution method development: development of a discriminating dissolution method for Sprycel film-coated tablets. J Pharm Innov. 2009; 4; 165-173. https://doi.org/10.1007/s12247-009-9071-5.
7. [7] Bhole R, Bonde C, Biradar P. Development and validation of stability indicating HPTLC method for estimation of dasatinib and characterization of degradation products by using mass spectroscopy. Eurasian J Anal Chem. 2018; 13(4): 1-11. https://doi.org/10.29333/ejac/90678.
8. [8] Panchumar(2018). thy R, Anusha S, Srinivasa Babu P. Development and validation of UV-Spectrophotometric method for determination of Dasatinib in bulk and pharmaceutical dosage form and its degradation behavior under various stress conditions. Int J Pharm Sci Rev Res. 2020; 53(2): 45-50.

9. [9] Lanke SV, Shekhawat DS, Niture N, Rusli RC, Shahnawaz SS. Novel HPLC method for determination of process related impurities of Dasatinib drug substance. Int J Sci Res. 2017; 6(11): 51-58. https://doi.org/10.21275/art20177411.
10. [10] Furlong MT, Agrawal S, Hawthorne D, Lago M, Unger S, Krueger L, Stouffer B. A validated LC–MS/MS assay for the simultaneous determination of the anti-leukemic agent dasatinib and two pharmacologically active metabolites in human plasma: Application to a clinical pharmacokinetic study. J Pharm Biomed Anal. 2012; 58: 130-135. https://doi.org/10.1016/j.jpba.2011.09.008.
11. [11] Bhagat NB. A review on development of biorelevant dissolution medium. J Drug Deliv Ther. 2014; 4(2): 140-148. https://doi.org/10.22270/jddt.v4i2.800.