Development of a New RP-HPLC Method for the Estimation of IBRUTINIB
Journal Title: Scholars Academic Journal of Pharmacy - Year 2017, Vol 6, Issue 12
Abstract
A simple, Precised, Accurate method was developed for the estimation of Ibrutinib by RP-HPLC technique. Chromatographic conditions used are stationary phase Agilent 150mm x 4.6 mm, 5m., Mobile phase buffer: acetonitrile in the ratio of 70:30 and flow rate was maintained at 1ml/min, detection wave length was 290nm, column temperature was set to 30oC and diluent was mobile phase Conditions were finalized as optimized method. System suitability parameters were studied by injecting the standard five times and results were well under the acceptance criteria. Linearity study was carried out between 25% to150 % levels, R2 value was found to be as 0.999. Precision was found to be 0.89 for repeatability and 0.66 for intermediate precision. LOD and LOQ are 0.13µg/ml and 0.39µg/ml respectively. By using above method assay of marketed formulation was carried out 101.21% was present. Degradation studies of Ibrutinib were done, in all conditions purity threshold was more than purity angle and within the acceptable range. Keywords:HPLC Ibrutinib, Method development. ICH Guidelines.
Authors and Affiliations
Narlapati Jagadeesh
Keywords
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