Simultaneous Estimation of Liraglutide and Preservative Phenol in Injectable Dosage Form by Validated Stability-indicating RP-HPLC Method

Abstract

Background: Ensuring the quality and stability of pharmaceutical formulations, especially peptide-based drugs like Liraglutide, requires reliable analytical methods. The simultaneous estimation of active drugs and preservatives using Reverse Phase High Performance Liquid Chromatography is essential for effective quality control and stability assessment. Aim: To develop and validate a simple, precise, accurate and stability-indicating reverse phase high-performance liquid chromatography method for simultaneous estimation of Liraglutide and Phenol in injectable dosage form. Study Design: An experimental analytical study aimed at the development and validation of a stability-indicating RP-HPLC method. Place and Duration of Study: The study was carried out in the pharmaceutical analysis laboratory during the period of dissertation research work. Methodology: Simultaneous estimation of Liraglutide and Phenol was achieved via chromatographic separation on a C18 column under optimized mobile phase conditions. Standard and sample solutions were prepared and analyzed using reverse phase high-performance liquid chromatography. The method was validated as per ICH guidelines, including specificity, linearity, accuracy, precision, robustness and sensitivity (LOD/LOQ). Forced degradation studies were performed under acidic, alkaline, oxidative, thermal and photolytic stress conditions to evaluate the stability-indicating nature of the method. Results: Liraglutide and Phenol showed well resolved peaks with retention times of 8.586 min and 3.265 min respectively. The method exhibited linearity in the concentration range of 30–90 µg/mL for Liraglutide and 27.50–82.50 µg/mL for Phenol, with correlation coefficients of 0.993 and 0.996 respectively. System suitability parameters were within acceptable limits, with a percentage relative standard deviation below 2%, theoretical plates above 2000, and a tailing factor below 2%. Moreover, forced degradation studies demonstrated that degradants from the major analytes did not interfere in the analysis Conclusion: This study confirms that the developed method is reliable, precise and efficient. It is suitable for the routine quality control and stability studies of Liraglutide injectable containing Phenol as a preservative.