Method Development and Validation of Stability Indicating Assay for Risperidone in Solid Dosage Form by Using HPTLC

Abstract

A simple, selective, rapid and precise stability indicating HPTLC method was developed for the quantitative estimation of risperidone in tablet dosage form and validated. The method was performed by using of HPTLC plates (Merck) pre-coated with silica gel 60F-254 on aluminium sheets and a mobile phase comprising of acetonitrile:triethylamine (5:0.2 v/v). Densiometric analysis of the drug was performed in the absorbance mode at 279 nm. The drug was subjected to acid-alkali hydrolysis, oxidation and photolytic degradation and was found to be susceptible to these methods. Linearity of risperidone was found to be 100-700 ng/spot (r² = 0.996). The limit of detection and limit of quantitation was found to be 46.56 and 141.12 ng/spot respectively for risperidone. The percentage recovery of risperidone was 99.08-99.95 %. The % RSD values for intraday precision study were < 1.0 % and for inter-day study were < 2.0 %, confirmed that the method was sufficiently precise. The validation studies were fulfil International Conference on Harmonization (ICH) requirements. The method was validated for the precision, robustness and recovery. Results revealing effective separation of the drug from its degradatied products confirm that it can be employed as a stability indicating method.