Spectroscopic analysis of Netilimicin by derivatization using Quality by Design for bulk dosage forms

ICH guidelines specifies the pharmaceuticals intended for human use in thecategory of Q 8,10,11 for the efficacy quality and safety of the intended product are in sync with the Quality by Design (QbD) principles, as quality by design isa risk based approach with pure scientific logics to establish a quality targetproduct profile[1] .Spectroscopic method approach for analysis of netilimicin wasperformed as per ICH Q8 (R2) guidelines. Quality by Design (QbD) was alsoincorporated by derivatization for which absorption spectra and absorptionmaxima were used, making it very simple and inexpensive methods.Spectroscopic analysis of netilimicin was performed using UV spectroscopykeeping in view the QbD principles as well as the limitation of beer’s law ,theaccuracy and precision of the method used were compared with the standard UVreference method ,for this three simple and sensitive methods were utilized,where pure sample of netilimicin was used in bulk dosage forms . (kumar et al,2018)Ishikawa diagram were used to depict the systemic approach to the study. Various critical parameter were studied for the proposed method, implemanding QbD principlies through spectrophotomerty utilized various method input variables like study of intensity of absorbance, absorbance maxima, spectral shapewhich were the validated as per ICH guidelines .