DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD OF GILTERITINIB IN BULK AND PHARMACEUTICAL DOSAGE FORM
*Parbati Kirtania, Nagma Sultana and Dr. Anupama Konneru
A simple, Précised, Accurate method was developed & validated for the evaluation of Gilteritinib by RP-HPLC
technique. Optimized variables used are stationary phase Ascentis C18 (150mm*4.6mm5μm), Mobile phase 0.1%
OPA: Acetonitrile (70:30) and at 1ml/min Flow rate, wave length was 214nm, column temperature was set to 30oC.
System suitability variables were calculated by inject the sample six times and results were within limit. Linearity
conducted between 25% to 150% levels, R2 value was get to be as 0.999. Precision was found to be 0.7 for
repeatability and 0.8 for intermediate precision. LOD and LOQ are 0.95μg/ml and 2.88μg/ml in that order. By
using above method assay of marketed formulation was conducted, 99.77% was there. Stability studies of
Gilteritinib were done, in all circumstances purity threshold was more than purity angle and within the limit.
Keywords: Gilteritinib, RP-HPLC, ICH Guidelines.
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