Abstract
The present investigation describes a simple, high speed, economic stability indicating RP-UHPLC method for the quantification of risperidone in self emulsifying lipid-based formulations and pharmaceutical solid dosage form. The drug was exposed to acid, base, hydrogen peroxide and thermal treatment to detect degradation compounds. The mobile phase was isocratic and composed of acetonitrile and formic acid. The flow rate was 0.4 mL/min in the column HSS C18 (2.1 x 50 mm, 1.8 mu m). The total sample run time (1 min) reflects the simplicity and rapidness while the result explained the reliability and precision of the method. The method was selective at 238 nm with sharp risperidone peak (0.7 min) and sensitive (LOD: 0.05 ppm and LLOQ: 0.5 ppm). The proposed UHPLC method is essential for the assessment of drug purity/stability and release from self-emulsifying lipid formulation and pharmaceutical solid dosage form during the dissolution/digestion studies without any interference of excipients and related degradation components.