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Validated RP-HPLC Method for Estimation of Related Impurities in Dasatinib


Bavireddi Mohan*, D. Ravi Kumar, R.S.K. Sharma, S.V. Murali Mohan Rao, N.V.S. Venugopal

Article (PDF)

Keywords

Dasatinib, Related Substances, Liquid Chromatography, Linearity and Reproducibility

Abstract

The analysis of HPLC-UV detector method for the quantification of Dasatinib and its related impurities was proposed in the present investigation. Analysis has been carried by means of reverse phase -HPLC using Waters XTerra MS C-18, (250 × 4.6 mm, 5 μ), and the mobile phase consists of two Channels A and B. Channel-A phosphate Buffer and Channel-B: Methanol and Acetonitrile (10:90). The column temperature was maintained at 40˚C and sample temperature was maintained at ambient and wavelength fixed at 265nm. The flow rate is 1.0 mL.min-1. It is found that the proposed method of RP-HPLC with UVdetection for the analysis of Dasatinib impurities are straight forward and applied in qualitative and quantitative analysis. The developed RP-HPLC method was validated as per ICH guidelines with respect to accuracy, linearity, reproducibility, ruggedness, robustness.