Development and Validation of Spectrophotometric Method for the Determination of Risperidone in Bulk Drug and Pharmaceutical Formulation by UV And HPLC

Abstract

Pharmaceutical chemistry encompasses all the major areas of chemistry; analytical, physical, organic and radiochemistry. It is a science that applies general laws of chemistry to come up with chemical nature, physiochemical composition, structures, and properties of drugs. The proposed spectrophotometric method was systematically in accordance with ICH guidelines, and the findings confirmed its reliability, sensitivity, and reproducibility. The λmax of risperidone was established at 202 nm, and from the optical characteristics (Table 2), the drug was shown to range of 2.5–20 µg/mL. Sensitivity of the method was further demonstrated through the calculation of LOD and LOQ, which were determined as 1.05 µg/mL and 3.34 µg/mL, respectively, using standard formulae (k = 3.3 for LOD and k = 10 for LOQ). These values highlight the method’s capacity to detect and quantify risperidone even at low concentration levels. Precision was confirmed through intra-day and inter-day analyses (Table 2), where %RSD values consistently remained below 2.0, ensuring reproducibility. Accuracy was validated by recovery studies (Table 3), with percentage recovery values exceeding 100%, demonstrating robustness and the absence of interference from formulation excipients. Stability testing further supported the method’s reliability, as both standard and sample solutions remained stable for at least 24 hours, with %RSD below 2.0 and no significant degradation observed. Finally, application of the method to tablet formulations (analyzed in triplicate) showed excellent agreement with the labeled claim (Table 4), confirming the suitability of the proposed method. Detecting even low quantities of risperidone is a beneficial application for quality control, stability studies, and regulatory compliance.