DEVELOPMENT AND VALIDATION OF AN ANALYTICAL METHOD FOR ESTIMATION OF TELMISARTAN AND METOPROLOL SUCCINATE BY UHPLC

Asarudeen A.*, Chitra M. and Senthilkumar Natesan

ABSTRACT

This study's objective was to design and validate a new Ultra-High-Performance Liquid Chromatography (UHPLC) method for the simultaneous determination of Telmisartan and Metoprolol Succinate in tablet formulations. This method was developed with an emphasis on accuracy, reproducibility, and a lower relative standard deviation (RSD), compliant with International Council for Harmonization (ICH) guidelines for method validation. The method's precision was confirmed by the low percent relative standard deviation (%RSD) values, with Telmisartan and Metoprolol Succinate recording 0.49 and 0.59 respectively. This implies the high reliability of the assay and retention times across repeated measurements. System suitability parameters were evaluated to ensure the efficiency of the chromatographic system, indicated by a plate count greater than 2000. A tailing factor below 2 further reinforced the method's efficiency, suggesting symmetrical and well-shaped peaks. The robustness of the method was further underscored by its excellent linearity. The linearity equations for Telmisartan (y = 0.0298x - 0.0285) and Metoprolol Succinate (y = 0.0686x + 0.1282) both produced correlation coefficients (R²) close to 1, demonstrating excellent linearity in the relationship between concentration and peak area. The method's accuracy was established by calculating the mean percent recovery after performing triplicate injections at each level. The method achieved high mean percent recovery values for both Telmisartan (98.95% and 100.19%) and Metoprolol Succinate (99.68% and 100.21%). Finally, the method precision and intermediate precision were confirmed by the low %RSD values for both drugs (0.27% for Telmisartan and 0.23% for Metoprolol Succinate), which fell below the acceptable limit of 2. The robustness of the method was further corroborated when system suitability parameters remained unaffected despite variations in conditions. In conclusion, the newly developed UHPLC method provides an efficient, robust, and precise tool for the simultaneous estimation of Telmisartan and Metoprolol Succinate in tablet formulations. This facilitates accurate drug content assessments in routine quality control tests for pharmaceutical companies. This study makes a significant contribution to the evolution of pharmaceutical analytical techniques, offering valuable insights into the use of validated UHPLC methods.

Keywords: Telmisartan, Metoprolol succinate, UHPLC, Method Validation.