STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF INOTUZUMAB OZOGAMICIN IN BULK DRUG AND INJECTION DOSAGE FORMAbstract
A simple, rapid, accurate, precise, and reproducible stability indicating RP-HPLC method for the estimation of Inotuzumab Ozogamicin in bulk and injection dosage form was developed and validated as per ICH guidelines. The separation was done using BDS C18 150 × 4.6 mm, 5 µ column. The mobile phase (Water and Acetonitrile 55:45% v/v) was pumped at 1.0 ml/min, and effluent was detected at 240 nm using a PDA detector. The retention time was 2.93 ± 0.1 min, and the method produced a linear response in the concentration range of 4.5-27 µg/ml (r2– 0.9995). In recovery studies, %RSD from reproducibility was found to be below 2%. LOD and LOQ were 0.1 µg/ml and 0.34 µg/ml, respectively. The drug was subjected to different stress conditions such as acidic, alkaline, oxidative, photothermal, and hydrolysis. The drug showed more degradation in acidic conditions, and no degradation was observed in hydrolysis and photo conditions. The developed RP-HPLC method was found to be effective, sensitive, and specific for the estimation of Inotuzumab Ozogamicin in bulk and injection dosage form.
T. Alluri * and E. P. Latha
Department of Pharmaceutical Analysis, CMR College of Pharmacy, Kandlakoya, Medchal, Telangana, India.
06 July 2019
15 April 2020
16 April 2020
01 June 2020