ESTIMATION OF PALIPERIDONE FROM BIOLOGICAL FLUID EMPLOYING INSTRUMENTAL PLANAR CHROMATOGRAPHY: BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION

Abstract

Paliperidone is an atypical antipsychotic agent widely used for the management of schizophrenia. An instrumental planar chromatography method assisted with liquid-liquid extraction for the estimation of Paliperidone from human plasma was developed. Chromatographic analysis included use of silica coated plates were used as stationary phase. Toluene: ethyl acetate: chloroform: methanol (2.5:2.5:2.5:2.5 v/v/v/v) was employed as the solvent system and detection was performed at 278 nm. The developed method was validated as per bioanalytical method validation M10 and analytical method validation Q2(R2) guidelines. The method exhibited a linear response over the concentration range of 12-48 ng/mL (60 240 ng/band). The method was found to be specific, sensitive, accuracy and reproducibility. The method found to satisfy all validation parameters and capable to of being applied for real sample analysis. This validated HPTLC method for estimation of Paliperidone in biological fluid provides an analytical basis for the quantitative determination of Paliperidone in biological matrices and can support the bioanalytical evaluation of Paliperidone-loaded nanostructured multiparticulate formulations and all other formulations of paliperidone.