Semaglutide and Liraglutide are two GLP-1 RA approved for treatment of type 2 diabetes.  The main aim of the present work is to develop a simple, precise, valid, speedy and decisive chromatographic strategy for the estimation of Semaglutide and Liraglutide quantitatively in fixed dosage form. Effective Chromatographic separation was achieved by using a Discovery C18 column of dimensions of (4.6 x 250 mm) and a particle size of 5µm. The mobile phase used was Phosphate buffer ph 4.0: ACN (pH 4.0) in the proportion of (30:70 % v/v). The mobile phase was pumped at 1.0 ml/min at an ambient temperature and the eluted analyte was identified at 254 nm.  Semaglutide and Liraglutide were eluted with a mean retention time of 2.507 min and 3.233 min.  The intended method was validated as per ICH (International Council for Harmonisation) guidelines, indicating a high degree of accuracy, precision, robustness, specificity and system suitability. The LOD (Limit of detection) and the limit of measurement did not exceed prescribed limit. The method linearity was found to be 0.992. The acceptance criteria of precision and Relative variance should be less than 2.0 which indicates that the method can be performed repeatedly. Reliability of the proposed method was assessed by evaluation of validation parameters like linearity, precision, specificity, accuracy, LOD, LOQ values as per ICH guidelines. The results obtained on the validation parameters met ICH and USP requirements. The proposed method of chromatography has been applied to dosage form without additives interference and is specific for the estimation of Semaglutide and Liraglutide.

Keywords: RP-HPLC; Quantification; Semaglutide; Liraglutide; Pharmaceutical Dosage Forms; Validation.