Analytical Method Development and Validation of Ubrogepant and their Degradation Studies in Bulk and Pharmaceutical Dosage form by RP-HPLC

Abstract

An accurate, rapid economical and straight forward, reliable new analytical method was developed and validated for the quantification of Ubrogepant and their degradation studies by using RP-HPLC.In the proposed method efficient chromatographic separation was achieved by using Ammonium aecetate buffer with pH adjusted to 5.0 with dilute Orthophosphoric acid solution and methanol (30:70 v/v) as a mobile phase with a flow of 1 ml/min and Water and Acetonitrile(30:70) is used as a diluent, the wave length was observed at 280 nm with isocratic mode at ambient temperature and run time was approximately 10 min and the retention time (Rt) of Ubrogepant was observed as 4.570 min. The method validated as per ICH guidelines. System suitability parameters were studied by injecting six standard solutions of Ubrogepant and results were well under acceptance criteria. Linearity study was administered between 25% to 150% levels, Regression coefficient value was observed as 0.999. LOD and LOQ were observed as 0.02 ug/ml and 0.2 ug/ml, respectively. Precision was found to be 0.54 for repeatability and 0.33 for intermediate precision. Recovery of the drug was found to be 100.86% indicates that the recovery is in the acceptable limit. Stress conditions of degradation in Acidic, Alkaline, Peroxide and Thermal were studied for Ubrogepant and validation results were found to be satisfactory and the proposed method was suitable for regular analysis and quality control of pharmaceutical preparations.