Abstract

RP-HPLC METHOD DEVELOPMENT AND METHOD VALIDATION FOR SIMULTANEOUS QUANTIFICATION OF DOMPERIDONE AND CINNARIZINE IN SOLID DOSAGE FORM

H. Durga Prasad*, Dr. K. Atchuta Kumar, Miss. N. Poojitha, Mrs. P. Prathyusha,

Abstract

Method development and validation is the process of developing and testing techniques for measuring the components of a product. It is a critical component of drug development and quality control. The main purpose is to guarantee that techniques for measuring drug identification, purity, potency, and stability are accurate, precise, and dependable. Analytical procedures are essential instruments for ensuring the safety, efficacy and quality of drugs during their development process. Using RP-HPLC, a simple and accurate technique for estimating Domperidone and Cinnarizine simultaneously was created. The peaks were well separated at 226nm in isocratic mode at 2.578 and 3.616 min retention times for Domperidone and Cinnarizine respectively at 1.2ml/min flow rate with Welchrom 250mm x 4.6mm, 5μm column for 20min. Orthophosphoric acid buffer: acetonoitrile (70:30) as mobile phase. The % Assay values for Domperidone and Cinnarizine were 99.76% and 99.85%, respectively. The linearity correlation coefficient was 0.9991 & 0.9992 for Domperidone and Cinnarizine respectively.

Keywords: Domperidone, Cinnarizine, Method development and validation, ICH guidelines, and RP-HPLC.