Abstract

METHOD DEVELOPMENT AND VALIDATION OF VALBENAZINE IN ITS BULK AND DOSAGE FORM BY HPLC

Imam Pasha S.*, Sumaiah Ahsan, Murali Balaram Varanasi and Anupama Koneru

Abstract

A simple and selective HPLC method is described for the determination of Valbenazine. Chromatographic separation was achieved on a Phenomenex C18 (250×4.6 ×5μ) using mobile phase consisting Acetonitrile : Water : Triethylamine buffer (60: 40: 0.5%) v/v with detection wavelength of 264 nm. Linearity was observed in the range 50-150 μg /ml for Valbenazine (r2 =0.999) for the amount of drugs estimated by the proposed methods was in good agreement with the label claim. The proposed method is fully validated with parameters like accuracy, precision, linearity, limit of detection, limit of quantification, robustness and ruggedness. The proposed method is stability indicating with parameters like Acid, base, peroxide, photolytic and thermal degradation.

Keywords: Valbenazine, HPLC, Method, Quantification, Formulation.