UV VISIBLE SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION OF DASATINIB IN BULK AND SOLID DOSAGE FORM
Keywords:Dasatinib, UV visible spectrophotometer, Methanol, Method development and validation
Objective: A new, simple, sensitive, precise, reproducible UV visible spectrophotometric method was developed for the determination of Dasatinib in Tablet dosage form with methanol.
Methods: The method is based on the formation of a colorlesscomplex. The UV spectrum of Dasatinib in methanol showed maximum wavelength at 248 nm. Beer’s law is valid in the concentration range of 7-35µg/ml. this method was validated for linearity, accuracy, precision, assay, ruggedness and robustness.
Results: The method has demonstrated excellent linearity over the range of 7-35µg/ml with the regression equation y = 0.0332x+0.0633 and regression coefficient i.e. r2= 0.9994moreover, the method was found to be highly sensitive with LOD(1.08µg/ml) and LOQ(3.29µg/ml).
Conclusion: Based on the results the proposed method can be successfully applied for the assay of Dasatinib in various tablet dosage forms.
2. https://en.wikipedia.org/wiki/Dasatinib [Last accessed on 15 Feb 2020]
3. Ramachandra B, Suguna P, Reddy KS, Naidu NVS. Development of a Uv-visible spectrophotometric method for the determination of dasatinib in pharmaceutical formulation and biological samples. Int J Pharm Sci Res 2015;6:293-303.
4. Vadia N, Rajput N. Development of the colorimetric method for determination of dasatinib in bulk and in tablet formulation. Int J Pharm Pharm Sci Rev 2011;3:188-90.
5. Panchumarthy R, Anusha S, Babu PS. Development and validation of the uv-spectrophotometric method for the determination of dasatinib in bulk and pharmaceutical dosage form and its degradation behavior under various stress conditions. Int J Pharm Sci Rev Res 2019;53:45-50.
6. Jadhav PB, Gajare GK. Development and validation of a UV-spectrometric method for estimation bosutinib in bulk and tablet dosage form. Int J Res Pharm Chem 2016;6:608-12.
7. Gowrisankar DG, Rajeswari A, Babu N, Vamsi KM. UV-spectrophotometric determination of dasatinib in pharmaceutical dosage forms. Asian J Chem 2009;21:5777-9.
8. Bandi R, Naidu NVS, Chandra KS. Validation of RP-HPLC method for estimation of dasatinib in bulk and its pharmaceutical dosage forms. Int J Pharm Biol Sci 2014;4:61-8.
9. Lanke SV, Syed SS, Singh SD, Niture NK. Rapid and sensitive RP-HPLC method for determination of potential genotoxic impurity in the dasatinib drug substance. Int J Chem Sci 2017;15:1-11.