Stability Indicating Spectroscopic and Chromatographic Estimation of Semaglutide

Abstract

New simple, economic and stable methods were developed and validated to estimate the Semaglutide using UV-Visible spectroscopy, HPLC and UPLC. 0.01N Potassium dihydrogen orthophosphate:Acetonitrile(61:39) used as solvent system. Method-I: At the maximum absorption wavelength of 230nm method was developed. Method-II: Kromasil C18 column selected as stationary phase. The flow rate and detector wavelength selected were 0.9 mL/min and 230nm respectively.  Study conducted by 5μL volume of injection at column temperature of 25°C.  RT was found to be 2.518min. Method-III: Acquity BEH-C18 (1.7 μ, 100×2.1mm) column selected as stationary phase. with the run time of 1.2min at 0.5ml/min flow rate method was optimized. The detection wavelength selected as 230nm.Rt was found to be 0.89min. Validation studies were conducted as per ICH guidelines.  From the linearity studies the range and correlation co-efficient were found be 1.5-9.0µg/ml&0.999 respectively for developed methods. The %RSD calculated in the intra-day and inter-day precision were less than 2. . From accuracy studies %recovery of drug were found be 98-102%. Under the accelerated conditions the drug degradation was less than 10%. Hence the developed methods were stable as pe the guidelines. From assay studies the % of dug present in the sample solution was between 99-102%. Hence the developed methods were suitable to separate the analyte present in the formulations.