Method development and validation for estimation of risperidone in novel liquisolid formulation by RP-HPLC

摘要

The aim of the present work is to develop and validate a simple, rapid and precise reverse phase high performance liquid chromatography method for determination of Risperidone (RIS) in novel liquisolid tablets. A Chemisil® octadecylsilane (ODS) C18 column (250 mm x 4.6 mm i.d) with 5 μ particle size was utilized as a stationary phase. Methanol : buffer (0.2% v/v OPA in HPLC water) in the ratio of 80 : 20 v/v was used as mobile phase, at a flow rate of 0.6 mL/min. Detection was carried out at 235 nm, using PDA detector. The total runtime and retention time was found to be 10 and 3.72 min respectively. The developed method was validated (according to ICH) with respect to linearity, accuracy (recovery), precision, specificity and robustness. Obtained results observed that all the parameters were within the limit. Linearity range and correlation co-efficient (r2) were 500 to 10000 ng/mL and 0.9969 respectively. The LOD and LOQ for RIS were found to be 364.07 ng/mL and 1103.26 ng/mL respectively. The developed method was simple, rapid, accurate, precise and sensitive for determination of RIS in novel liquisolid tablets and can be routinely employed inthe quality control.