Quality by design for pharmaceuticals. Netillimicin qbd

      Аннотация: ICH guidelines specify the pharmaceuticals intended for human use in the category 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 is a risk-based approach with pure scientific logics to establish a quality target product profile[1]. The spectroscopic method approach for analysis of netilmicin was performed as per ICH Q8 (R2) guidelines. Quality by Design (QbD) was also incorporated by derivatization for which absorption spectra and absorption maxima were used, making it very simple and inexpensive methods. Spectroscopic analysis of netilmicin was performed using UV spectroscopy keeping in view the QbD principles as well as the limitation of beer’s law, the accuracy and precision of the method used were compared with the standard UV reference method, for this three simple and sensitive methods were utilized, where a pure sample of netilmicin was used in bulk dosage forms. (Kumar et al, 2018)Ishikawa diagram was used to depict the systemic approach to the study.

Ключевые слова: ICH Q8 (R2); UV Spectroscopy;Ishikawa Diagram, ;Critical parameters Analytical quality by design A(QbD)