Stability Indicating RP-HPLC Method Development and Validation for Bosentan in Pharmaceutical Formulations

Authors : Mehmet Emrah YAMAN, Alptuğ ATİLA, Yücel KADIOĞLU

Pages : 505-512

Doi:10.18596/jotcsa.956110

View : 14 | Download : 7

Publication Date : 2022-05-31

Article Type : Research Paper

Abstract :The development and validation of a novel, simple, and quick HPLC technique for measuring bosentan in pharmaceutical formulations was performed. The technique parameters were tuned to be 1 mL/min flow rate, variable column temperature, and a mobile phase combination of methanol-acetonitrile-water insert ignore into journalissuearticles values(20:50:30 v/v/v); to carry out this study. All measurements were carried out with a UV detector at a wavelength of 272 nm. Specificity, the limit of quantitation insert ignore into journalissuearticles values(LOQ);, limit of detection insert ignore into journalissuearticles values(LOD);, linearity, accuracy, precision, stability, recovery, and ruggedness were all tested. The technique was linear between 0.25 and 20 µg/mL, with precision insert ignore into journalissuearticles values(RSD%); and accuracy insert ignore into journalissuearticles values(RE%); of less than 3.0 and 2.7%, respectively. The LOQ and LOD values of method were 0.25 and 0.1 µg/mL, respectively. The 10 µg/mL of standard bosentan solution was found to be moderately stable in acidic and basic settings insert ignore into journalissuearticles values(0.1 M HCl and 0.1 M NaOH); but unstable in an oxidative environment insert ignore into journalissuearticles values(H2O2 solution; 3%);. No interference from tablet excipients was observed in the HPLC method. The approach was successfully applied to pharmaceutical formulations obtained from a local pharmacy store.
Keywords : Bosentan, HPLC analysis, Drug degradation, Bioanalytical Method Validation