Development of Stability Indicating RP-HPLC Method for Determination of Levosulpiride Hydrochloride In Bulk And Pharmaceutical Dosage Form

Abstract

A rapid, specific and sensitive stability indicating reverse phase high performance liquid chromatographic method has been developed and validated for analysis of levosulpiride hydrochloride in both bulk and pharmaceutical dosage form. An isocratic stability indicating reversed-phase liquid chromatographic determination was developed for the quantitative determination of levosulpiride in the pharmaceutical dosage form. A sunfire C-18, 4.5mm column with mobile phase containing methanol-water (10:90, v/v) was used. The flow rate was 1.0 mL min ^-1 and effluents were monitored at 232 nm. The retention time of Levosulpiride was 5.5 min. Levosulpiride stock solutions were subjected to acid and alkali hydrolysis, chemical oxidation, wet hydrolysis, dry heat degradation and sun light degradation. The degraded product peaks were well resolved from the pure drug peak with significant difference in their retention time values. Stressed samples were assayed using developed LC method. The proposed method was validated with respect to linearity, accuracy, precision and robustness. The method was successfully applied to the estimation of Levosulpiride in tablet dosage forms. The proposed study describes stability indicating LC method for the estimation of Levosulpiride in bulk and their pharmaceutical dosage form. The method is suitable for the routine analysis of Levosulpiride in tablets.