STABILITY INDICATING RPHPLC METHOD DEVELOPMENT AND VALIDATION FOR DETERMINATION OF GLP-1R AGONIST SEMAGLUTIDE

Abstract

Semaglutide was estimated using a stability-indicating RP-HPLC method that was developed and validated. A Credence Scientific C18 analytical column (250 x 4.6 mm, internal diameter, 5 µm particle size) served as the stationary phase, and Phosphate buffer (pH-6.8): Acetonitrile (30:70) v/v served as the mobile phase. 20 µl was the injection volume. While keeping the flow rate at 1 ml/min, effluents were seen at 220 nm. 1.8 minutes was determined to be the retention time. ICH recommendations were followed when conducting the forced deterioration tests in acidic, alkaline, oxidative, thermal, and photo stability settings. The degradation studies clearly demonstrated the drug's fragility in these settings. The linearity of the technique was seen in the concentration range of 10–50 µg/ml, with theoretical plate and tailing factor values of 708.845 and 1.451, respectively, and a correlation coefficient of 0.9996. The precision, accuracy, and system-applicability of the approach were verified. The study's findings were within the parameters of ICH standards, hence this approach can be used to estimate Semaglutide.