A new and stability-indicatingreversed-phase ultra performance liquid chromatographymethod was developed and validated for simultaneous determination of clofarabine impurities in Injectionformulation. The chromatographic separation was carried out on an ACQUITY UPLC® CSH C18 (50mm x 2.1mm, 1.7µm)using a mobile phase consisting of Ammonium formate buffer with pH 3.0 andacetonitrile at a flow rate of 0.28 ml/min and an injection volume of 1µL. The method was validated for precision, accuracy, specificity, linearity, sensitivity and robustness. The UV detection was performed at 264 nm.The proposed method can be applied for quality control, release and stability analysis of clofarabine and its impurities in Injection formulation.
Keywords : Clofarabine, Stability-indicating, UPLC, Validation.