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