Development and Validation of Analytical Methods for the Estimation of Anti Psychotic Drugs in Pharmaceutical Dosage Form

Abstract

LOXAPINE SUCCINATE: The goal of present research work has to develop a simple, sensitive, specific isocratic (SIAM) stability indicating assay method and related substance method for the determination of Loxapine succinate in capsule dosage form by HPLC method. Chromatographic separation for stability indicating assay method has been achieved on C18 Purospher star;(250mm ×4.6 newlinemm,5µm) with elution solvent comprised of Water:Methanol:ACN:TEA in the ratio of 40:10:50:1 ml respectively and retained at rate of flow of 1.0 ml/min and the observation wavelength 254 nm. Chromatographic separation for related substance method has been achieved on C18 Purospher star;(250mm ×4.6 mm,5µm) with elution solvent comprised of Water:methanol:TEA:THF in the ration newlineof 50:40:1:10 ml respectively and retained at rate of flow 1.0 ml/min and the observation wavelength 254 nm. Developed procedure has to be validated in accordance with ICH guidelines. Results for validation parameter met the predefined acceptance criteria. newlineCLOBAZAM: The goal of present research has to develop a simple, sensitive, specific isocratic stability indicating assay method and related substance method for the estimation of Clobazam in tablet dosage form by HPLC method. Chromatographic separation for stability indicating assay method has been achieved on Hypersil ODS (250*4.6mm, 5µm) with elution solvent comprised of newlineWater : Acetonitrile (45:55) and retained at rate of flow 1.0 ml/min and the observation wavelength 289 nm. Chromatographic separation for related substance method has been achieved on Hypersil ODS (250mm × 4.6mm), 5 and#61549;m particle size with gradient elution solvent comprised of elution solvent newlineA water and elution solvent B acetonitrile and retained at rate of flow 1.0 ml/min and the observation wavelength 289 nm. Developed method has been validated in accordance with ICH guidelines. Results for validation parameter met the predefined acceptance criteria.