Published Paper Details:

Bosentan HCL, a widely used pharmaceutical compound, necessitates precise and reliable analytical methods for its estimation in bulk. This study focuses on the development and validation of an analytical method for the quantitative determination of Bosentan HCL in bulk samples. Various analytical techniques, including high-performance liquid chromatography (HPLC), UV-Visible spectrophotometry, and titrimetric methods, were explored for their suitability in Bosentan HCL analysis. The developed method involves the utilization of HPLC due to its high sensitivity, specificity, and reproducibility. Parameters such as mobile phase composition, column type, wavelength, flow rate, and injection volume were optimized to achieve robust separation and quantification of Bosentan HCL. Method validation was performed according to International Conference on Harmonization (ICH) guidelines, encompassing specificity, linearity, accuracy, precision, and robustness studies. The developed HPLC method exhibited excellent linearity over a wide concentration range, with good precision and accuracy. Specificity studies confirmed the absence of interference from potential impurities or excipients present in bulk samples. Validation results demonstrated the reliability and suitability of the developed method for Bosentan HCL estimation in bulk materials. This validated analytical method provides a valuable tool for quality control laboratories, pharmaceutical industries, and regulatory authorities involved in the assessment of Bosentan HCL raw materials and formulations. Moreover, it contributes to ensuring the safety, efficacy, and quality of pharmaceutical products containing Bosentan HCL. This abstract outlines the importance of developing an accurate and reliable method for the estimation of Bosentan HCL in bulk, the approach taken in the study, and the validation of the developed method according to regulatory standards.