Response Surface Methodology-driven RP-HPLC-PDA Approach to Analytical Method Development, Validation, and Quantitation of Ixazomib in its Pharmaceutical Formulations.

INTRODUCTION: The second most common malignancy in adults that impairs immune function is multiple myeloma. For the treatment of this kind of cancer, Ixazomib is one of the second-generation medications used. It is a reversible oral proteasome inhibitor.

METHOD: A response surface approach using the RP-HPLC method was established to analyze the drug. A Waters Alliance 2695e RP-HPLC unit with a 2998 PDA detector and a Zorbax SB C18 Analytical column (75˟4.6mm˟5μm particle size) was used for the study. The study was conducted at 215 nm to separate the drug. A total of 13 runs were suggested by the CCD experimental design and were conducted to optimize the method. Using an arithmetic model, the effects of dependent variables on the responses were examined.

RESULTS: The ideal experimental conditions for the proposed study include a mobile phase comprising acetonitrile and an aqueous solution of glacial acetic acid and sodium salt of 1- hexanesulfonic acid (30:70% v/v). Over the concentration range of 25-750 μg/mL, a linear calibration curve was obtained. Recoveries ranged from 99% to 101% across three concentrations.

DISCUSSION: The Design Expert version 13 software was used to conduct the statistical evaluation of the runs. The analysis suggests that the most significant parameters influencing the intended responses were column temperature and flow rate, as indicated by the 3D response surface curves.

CONCLUSION: The developed method demonstrated remarkable results across different analyses within the limits of estimation for Ixazomib. Forced degradation studies and solution stability studies also confirmed the drug's stability. This indicates that the suggested method could be a valuable technique for the precise and accurate estimation of Ixazomib.