Development of Validated Analytical Methods for Selected Cardiovascular Drugs in Formulations and Its Application in In Vitro Interaction studies

Abstract

The development and validation of different analytical techniques for the selected cardiovascular drugs (dronedarone hydrochloride, levosimendan, rivaroxaban and ticagrelor) were successfully carried out. All the developed methods have been validated as per ICH guideline for validation of analytical method. The analytical methods developed are having its own advantages for using them in routine quality control process. The in-vitro drug interaction of selected CVD drugs with certain coadministered drugs was carried out by applying the developed RP-HPLC method. The second order derivative UV spectroscopic method for determination of dronedarone hydrochloride is a simple and accurate method. The second order spectrum were in good resolution when compare to zero order spectrum of dronedarone hydrochloride tablets. The spectrofluroimetric method developed utilized simple oxidation method with acidic CAS solution. The UV spectrophtotometric method and spectrofluorimetric method developed for determination of levosimendan are very simple. The validation results of these methods demonstrate they are highly reliable. The developed HPTLC method resulted lower LOD and LOQ values of levosimendan described the greater sensitivity of the method. The HPLC method developed used simple mobile phase composition and the method is not laborious as reported methods. The results of spectrophotometric method for the determination of rivaroxaban revealed it is accurate, stable and precise. The spectroflurimetric method results described the method is extremely sensitive for the determination of rivaroxaban in very low concentrations and it is a good alternative for high cost methods. The UV spectrophotometric method for determination of ticagrelor was having greater sensitivity than the HPLC method. The developed HPTLC method for newlineticagrelor revealed the method is simple and time saving for the analysis of multiple samples in single run. The recoveries of ticagrelor were also found to be excellent. newline newline newline