DOI: 10.21276/ajptr
Sat, 25 May 2019

Quality-By-Design (QBY) Approach RP-HPLC Method for the Estimation of Nilotinib Hydrochloride and Impurities in Drug Substance

Srikanth Munipalli1*, Mariappan Soundarapandian1, Tulasirao V1, V S Prakash Reddy T1, Jeenet Jayachandran1, Manish Gangrade1

1. Integrated Product Development, Research and Development Division, Cipla Limited, Bangalore, Karnataka, India.


The RP-HPLC method development is to define a quality of the product and its process impurities to consistently deliver the intended quality of the drug substance. All the methods which are published are developed through knowledge base, traditional systematic scientific approach. The established method development for Nilotinib hydrochloride was through the vision of “Quality-by-Design” (QbD) approach to estimate the analytical target profile of the target analyte. The robustness of the method has been achieved with an emphasis on establishing the ‘design space’ of the method through the statistical model to ensure the establishment and use of knowledge on the subject. The proposed chromatographic method as Zorbax SB Phenyl (150mmX4.6mmX3.5µm) column thermo stated 45°C using 15 mM potassium dihydrogen phosphate (KH2PO4) with pH-3.5 and Acetonitrile for the gradient elution with the flow rate of 1.0 mL/min. The detection was carried out with the VWD/PDA detector at 240nm. The established design space has been validated against the critical quality attributes (CQA) of the method within the regulatory framework.

Keywords: Quality-by-Design, critical Quality Attributes, DoE, Design Space.

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