The analytical procedure for determination of Assay in finished product of Clofarabine Injection, 1mg/mL is an In-House procedure.

ABSTRACT

A new and stability-indicating High performance liquid chromatographymethod was developed and validated for simultaneous determination of clofarabine impurities in Injectionformulation.The Chromatographic system consisted of a Shimadzu Class VP Binary pump LC-10ATvp, SIL-10ADvp Auto sampler, CTO-10Avp Column Temperature Oven, SPD-10Avp UV-Visible Detector.The method was validated as per the ICH guidelines Apart from these Chromatographic parameters likeresolution, capacity factor, separation factor, column efficiency and peakasymmetry should also be the ideal for estimation.