Method Development and Validation of Risperidone by Rp-hplc

INTRODUCTION Resperidone chemically 4-[2-[4-(6-fluorobenzo [d] isoxazol-3-yl)-1-piper idyl] ethyl] -3methyl-2, 6diazabicyclo [4.4.0] deca-1, 3-dien-5-one. This drug belongs to a class of Anti-psychotic known as atypical neuroleptics. It is a strong dopamine antagonist. It has high affinity for D2 dopaminergic receptors. It has actions at several 5-HT (serotonin) receptor subtypes. The latter action may lead to an increased release of dopamine from mesocortical ABSTRACT An isocratic Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method has been developed and subsequently validated to develop new simple and rapid analytical method to estimate the Resperidone in pharmaceutical dosage form. As the drug is polar in nature, it was proposed to select isocratic RP-HPLC method. The separation was achieved with an LC-2010CHT SHIMADZU C18 (150 x 4.6 mm), 5 μm column and Methanol: Acetonitrile: Potasium dihydrogen ortho phosphate (60:30:10v/v/v) as a eluent, at flow rate 1.0 mL/min. UV detection was performed at 234nm. The developed method was validated by accessing various parameters like specificity, linearity, LOD, LOQ, precision, robustness, ruggedness and system suitability studies. From the results it was found that all the parameters are within the acceptable range. Hence the proposed method was found to be satisfactory and would be used for the routine quality control analysis of Risperidonel bulk and Formulation.