Development of method and validation for Assay in Cyclizine Hydrochloride Injection by Applying Stability Indicating HPLC Methodology by HPLC

Abstract

A validated HPLC method is developed to determine Cyclizine Hydrochloride (CYHC) in pharmaceutical formulation. Isocratic elution at a flow rate of 1.0 ml/min was employed on C18 5 µm (150 x 4.6 mm), 4µm or equivalent column, or similar is used for this chromatography analysis. Ammonimum acetate, acetonitrile, Glacial acetic acid, and triethylamine are used as a buffer solution. Mobile phase is 10mM ammonium acetate as 64v/v, acetonitrile as 35v/v, and triethylamine as 1v/v. The UV detection wavelength was 254nm, and 20.0µl sample was injected. The run time is 55 minutes for diluted standard and 30 minutes for sample, blank, placebo, system suitability, sensitivity solution. The retention time is ± 2.1min. The% R.S.D CYHC is identified. The mean Percentage recovery for Irinotecan is found within the specification limit. Thus, the proposed HPLC method can be successfully applied for routine quality control analysis formulations. The method developed is simple and is better than the methods reported in the literature.