QBD approach to develop stability indicating RP-HPLC method development for Levosulpiride and Ilaprazole

Objectives: As per requisition of current regulatory requirements, simple, rapid and sensitive method by 33 factorial QbD approach was established validated for Levosulpiride Ilaprazole RP-HPLC. Method: A simple RP-HPLC has been developed with different parameters such as linearity, precision, repeatability, LOD, LOQ, accuracy ICH guidelines (Q2R1). Statistical data analysis done obtained from aliquots Runs on Agilent Tech. Gradient System Auto injector, UV (DAD) & Detector. Results: Equipped Reverse Phase (Agilent) C18 column (4.6mm x 250mm; 5µm), a 20µl injection loop UV730D Absorbance detector at 219 nm wave length running chemstation 10.1 software drugs along degradants were separated via Methanol: (0.1% OPA) Water (45:55) pH 3.2 mobile phase setting flow rate 0.6 ml/min ambient temperature, retention time 4.257 min 5.547 min. good peak shape (Theoretical plates 6972 3521 Ilaprazole). The LOD LOQ found to be 1.8208μg/ml 5.5176μg/ml. 0.3676μg/ml 1.1139 μg/ml analytical that concluded.