Development and Validation of Novel Stability...

Development and Validation of Novel Stability-Indicating RP-HPLC Method for Determination of Semaglutide in Tablet Dosage Form

Author Name : Padmanabh B. Deshpande, Aarti Khadtare, Pratiksha Shinde, Rutuja Parit, Vaishnavi Kohakade

ABSTRACT

A new simple, accurate and precise stability-indicating RP-HPLC analytical method has been developed and validated for the quantitative analysis of Semaglutide as bulk drugin tablet dosage form. The objective of this study was to explore Semaglutide degradation behavior under ICH-recommended stress conditions, employing a newly designed stability indicating HPLC method and validating it. The method was developed on Agilent eclipse C8 (150 mm × 4.6 mm) column with Methanol: 0.05 M Phosphate Buffer (pH 5) (65: 35, v/v) as mobile phase using simple isocratic elution technique. The retention time was found to be 3.6 min.The developed procedure was successfully validated as per ICH Q2 (R1) guidelines. The developed method was found to be linear within the range of 5-30 µg mL^-1 (R² =0.994), precise as % RSD for Inter-day and Intra-day Precision were found to be < 2 %, accurate as % recovery values in accuracy study was found to be in range of 98-102 % and sensitive as limit of detection and limit of quantitation were found to be 0.97 µg mL^-1 and 2.93 µg mL^-1 respectively. We provide simple and fast analytical method that can be utilized as quality control tool for the determination of Semaglutide as bulk and in its tablet formulation.

Keywords: Semaglutide, Stress degradation, Stability indicating, RP-HPLC