The New RP-HPLC Method for Simultaneous Quantification of Cinnarizine, its Five Specified Impurities, Two Degradation Products with Two Antioxidants and Confirmation of all by HPLC-ESI-MS in Different Pharmaceutical Drug Formulations

To determine the safety and efficacy, we have developed validated RP-HPLC method for simultaneous quantification of cinnarizine, its five specified impurities two degradation products in cinnarizine API, tablets capsules including antioxidants an oral suspension formulation. The chromatographic separation was achieved gradient elution mode with 1.00mL/min flow on Ascentis Express C18 (150mm, 4.6mm 2.7µm particle size) column at 40.0°C temperature using 0.05% acetic acid mixtures 10mM ammonium acetate acetonitrile. All peaks are eluted within 30 minutes a 10µL injection volume detected 230nm wavelength. results validation proposed as per ICH guidelines revealed that is specific, accurate, precise, linear robust purposes. recoveries all impurities, lower concentration were found range 100.0±10.0%. While assay values 100.0±2.0% (methylparaben propylparaben). LOD LOQ 0.1125µg/mL 0.1875µg/mL, respectively. linearity curves ten analytes mentioned above showed good (r≥0.999). This research work presents first unknown well HPLC-ESI-MS correct identification confirmation results.