METHOD DEVELOPMENT AND VALIDATION OF IXAZOMIB DRUG BY RP-HPLC IN BULK AND PHARMACEUTICAL DOSAGE FORM

Abstract

A novel approach was used for develop and validate a rapid, accurate, and an isocratic RP-HPLC method with PDA detector for the estimation of ixazomib drug in pharmaceutical dosage forms. Ixazomib was seperated using Agilent 4.6*150 mm, 5μm analytical column, a Waters HPLC system (USA) and a mobile phase consisting of water and acetonitrile in the ratio of 40:60 V/V. The flow rate was set to 0.7 mL/min with 10µL injection volume. The column was maintained at ambient temperature, detector was set at wavelength of 274 nm. The retention time of ixazomib was found to be 2.17 min. The system suitability parameters for ixazomib such as theoretical plates and tailing factor were found to be 4146. Linearity was established for ixazomib such as theoretical plates and telling factor were found to be 4146. Linearilty was established for ixazomib in the range of 50-250 µg/ml concentration levels with correlation coefficients (r2) of 0.999. The intra-and inter-day precision % RSD values were found to be 0.47 and 0.31, respectively. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 2.03 and 6.17 µg/mL respectively. The method was validated for all of the above parameters according to the International Conference on Harmonization (ICH) guidelines. This method can be used for estimation and analysis of ixazomib drug in active pharmaceutical ingredients and pharmaceuticals.