Stability Indicating RP-UPLC Method Development Validation and Dissolution Testing of Semaglutide

Abstract

A rapid, accurate, precise and stability indicating RP- UPLC method was developed to determine the Semaglutide present in the bulk and dosage forms. BEH-C18 (1.7 μ, 100×2.1mm) column selected as stationary phase and 0.01N Potassium dihydrogen ortho phosphate: Acetonitrile (60:40) selected as mobile phase. The run time is 1.2min and 0.5ml/min flow rate selected to optimize the method. The retention time of Semaglutide recorded as 0.89min at the detection wavelength of 230nm. Concentration range of linearity recorded 1.5-9.0 µg/ml and correlation co-efficient of 0.999. %RSD found in intra-day and inter-day precisions were 0.2. The % recovery of drug at the concentration levels of 50%, 100% and 150% were 100.02%, 99.98% and 99.99% respectively. The developed method was robust. Under the stress conditions like acid, base, neutral, oxidative, thermal and UV light the drug degradation was less than 10% and the analyte peak can separate under this stress condition without interaction of degradation products. The developed method can able to separate the active ingredients present in the formulation without interference of excipient.