SPECTROPHOTOMETRIC DETERMINATION OF DASATINIB IN PHARMACEUTICAL FORMULATIONS
Keywords:Dasatinib, Bioanalytical method, Spectrophotometry, Chloranilic acid, Method development, Validation
Objective: A new, simple, sensitive, precise and reproducible bioanalytical method was developed for the determination of Dasatinib in pharmaceutical formulations with Chloranilic acid.
Methods: The method is based on formation of violet colored complex. The UV spectrum of Dasatinib in methanol showed λ max at 521 nm. Beer’s law is valid in the concentration range of 10-60 μg/ml. This method was validated for linearity, accuracy, precision, ruggedness and robustness.
Results: The method has demonstrated excellent linearity over the range of 10-60 μg/ml with regression equation y = 0.021x-0.083 and regression correlation coefficient r2= 0.997. Moreover, the method was found to be highly sensitive with LOD (2.96μg/ml) and LOQ (8.98μg/ml).
Conclusion: Based on results the proposed method can be successfully applied for the assay of Dasatinib in various pharmaceutical dosageforms.
2. NV Naidu. Development of UV-visible spectrophotometric method for determination of dasatinib in pharmaceutical formulation and biological samples. Int J Pharm 2015;6:293-303.
3. http://www.accessdata.fda.gov [Last accessed on 10 Oct 2019]
4. M Yasim Begum. Formulation and evaluation of dasatinib loaded solid lipid nanoparticles. Int J Pharm 2018;10:14-20.
5. Lakshmana Rao, A Sreedevi. Development and validation of novel HPLC method for the estimation of dasatinib in bulk and pharmaceutical dosage forms. Int J Res Pharm Chem 2013;3:724-9.
6. Alagar RM. RP-HPLC method for estimation of dasatinib in active pharmaceutical ingredient and pharmaceutical dosage form as per ich guidelines. Asian J Pharm Anal Med Chem 2015;3:109-16.
7. Panchumarthy Ravisankar, S Anusha, P Srinivasa Babu. Development and validation of UV-spectrophotometric method for determination of dasatinib in bulk and pharmaceutical dosage form and its degradation behaviour under various stress conditions. Int J Pharm Sci Rev Res 2018;53:45-50.
8. D Gowri Sankar, A Rajeswari, A Nagesh Babu, M Vamsi Krishna. UV-spectrophotometric determination of dasatinib in pharmaceutical dosage forms. Asian J Chem 2009;21:5777-9.
9. B Ramachandra, K Sivarami Reddy, T Niranjan, N Venkatasubba Naidu. Spectrophotometric method for the determination of dasatinib in pharmaceutical formulations and human blood samples with BPB. Int J Chem Concepts 2015;1:26-33.
10. Vatchavai Bhaskara Raju, Bonthu Mohan Gandhi. Development and validation of new RP-HPLC method for the estimation of dasatinib in pharmaceutical dosage forms. Asian J Pharm Technol Innovation 2017;5:7–12.