RESEARCH PAPER
Validated RP-HPLC method for estimation of related impurities in Dasatinib
 
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1
Chemistry, Gitam University(Deemed to be University), India
2
Chemistry, Krishna University Dr.MRAR PG Centre, India
3
Chemistry, Gitam University, India
CORRESPONDING AUTHOR
Bavireddi Mohan   

Chemistry, Gitam University(Deemed to be University), 530045, Vishakapatnam, India
Publication date: 2020-04-02
 
Eurasian J Anal Chem 2020;15(1):emEJAC-00311
 
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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.

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