Quality By Design Approach for Developing a Validated Liquid Chromatographic Method for Simultaneous Quantification of Bosentan and Sildenafil Citrate with Applications in Dissolution and Robustness Studies
Abstract
Background: This research aims to establish a validated analytical procedure for the simultaneous quantification of bosentan and sildenafil citrate in a newly encapsulated mini tablet formulation. Methods: The chromatography was performed using a reverse-phase column with a mobile phase consisting of acetonitrile and phosphate buffer at pH 4.3 in a ratio of 75:25 (v/v). The flow rate was maintained at 0.9 mL/min, and detection was conducted at a wavelength of 280 nm. Results: The developed method demonstrated excellent linearity, with a concentration range of 1–160 µg/mL for both bosentan and sildenafil. Method validation results adhered to acceptable limits established by regulatory guidelines. Additionally, the use of a quality by design approach ensured optimum robustness of the analytical method. Conclusion: This validated procedure is suitable for routine quality control of bosentan and sildenafil in the newly developed combined solid oral dosage form, providing a reliable analytical framework for future studies.
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