DEPELOPMENT AND VALIDATION OF RP- HPLC METHOD FOR DETERMINATION OF ARIPRAZOLE IN HUMAN PLASMA

Abstract

The aripiprazole concentration in human plasma was determined utilizing a simple, precise, and accurate RP-HPLC (Reverse phase -high 
performance liquid chromatographic) method using voriconazole as the internal standard. Chromatographic settings included a phenomenex 
C18 (150 x 4.6 x 5 m) stationary phase, 0.01N potassium dehydrogenate phosphate (pH 4.8) mobile phase, acetonitrile and water at a 60:40 
(v/v) ratio, a 1.0 ml/min flow rate, a 218 nm detection wavelength, and a 300 C column temperature. Results showed that Aripiprazole had a 
retention duration of 3,113 minutes and a coefficient of variation (CV) of less than 2%. The linearity of the suggested approach was studied 
throughout a concentration range of 10-400 ng/mL (r2 =0.999), and a recovery of 98.12% was determined. Detection levels as low as 
10ng/mL were achieved, which is close to the concentrations of the substance that could be present in human plasma. Furthermore, the 
disclosed approach was shown to work in human plasma and verified in accordance with ICH principles. The disclosed approach was also 
verified in accordance with ICH recommendations and found to be within acceptable limits.