STABILITY INDICATING RP-HPLC METHOD FOR THE DEVELOPMENT AND VALIDATION OF DASIGLUCAGON IN BULK AND PHARMACEUTICAL DOSAGE FORMS

Abstract

Targeted RP-HPLC methodology for the quantification of Dasiglucagon in pharmaceutical formulations. The chromatogram was analysed using an Agilent 150, 4.6 mm, 5μm column. Orthophosphoric acid and acetonitrile were combined in an 80:20 ratio and pushed through the column at a flow rate of 1.0 ml/min. The temperature was sustained at 30°C. The chosen optimised wavelength was 271.0 nm. The retention time of Dasiglucagon was determined to be 2.171 minutes. %The relative standard deviation (RSD) of Dasiglucagon was determined to be 0.2%. The method precision RSD for Dasiglucagon was found to be 0.5%.The recovery rate for Dasiglucagon was 99.72%. The LOD and LOQ values derived from the regression equation for Dasiglucagon are 0.03 and 0.09, respectively. The regression equation is expressed as y = 135330x + 20334. The retention durations and run times were reduced, indicating that the new approach is straightforward and cost-effective, suitable for routine quality control testing in industries.