Acta Scientific Pharmaceutical Sciences (ISSN: 2581-5423) Volume 5 Issue 3 March 2021 Development of a Novel Method for Determination of Risperidone in Pharmaceutical Products and its Quality Control Application Mohamed Raslan 1,2 , Sara AS 2 , Eslam MS 2 and Nagwa A Sabri 1 * 1 Department of Clinical Pharmacy, Faculty of Pharmacy-Ain Shams University, Cairo, Egypt 2 Drug Research Centre, Cairo, Egypt *Corresponding Author: Nagwa A Sabri, Department of Clinical Pharmacy, Faculty of Pharmacy-Ain Shams University, Cairo, Egypt. Research Article Received: February 13, 2021 Published: February 27, 2021 © All rights are reserved by Nagwa A Sabri., et al. Abstract Background: Risperidone is an antipsychotic drug that is selective to dopamine D2 and serotonin 5-HT2A receptors and used in the management of schizophrenia, and bipolar mania. Aim: The work objective was to establish a specific, accurate, and sensitive analytical method for the quantification of risperidone in pharmaceutical dosage forms. The method will be used as a quality control tool for testing pre-market and post-market distribution of risperidone products, ensuring that the dosage forms are fulfilling the required labeled amount of the drug. Methods: Evaluation of risperidone in commercial pharmaceutical products administered in hospitals, community pharmacies, and other health care facilities by the development of a high-performance liquid chromatographic (HPLC) method to add a validated sensitive and selective method to literature methods. Results: The method showed specificity, sensitivity, and selectivity, and linearity (R 2 >0.999) within concentration range of 0.2 to 6 µg/mL for dissolution medium USP (0.1N HCl), and 0.1 to 3.4 µg/mL for dissolution medium pH1.2, 4.5, and 6.8. Accuracy percentage within 98 - 102%, and precision percentage below 2%. The mean recovery of assayed tablets is 100.113%. In addition, dissolution results meet the required 80% dissolution limit within 10 minutes. Conclusion: The developed analytical technique is fully validated and applicable for use in the quantitative analysis of risperidone. Keywords: Risperidone; Analytical Method; Schizophrenia; Bipolar Mania; Pharmacopeia; Dissolution; Validation Introduction Risperidone is an antipsychotic drug that acts as an antagonist for dopamine D2 and 5-HT2A receptors. Risperidone displayed remarkable therapeutic efficacy in the treatment of schizophrenia and bipolar mania in adults [1]. Risperidone is currently one of the most widely used antipsy- chotic medications for the management of acute schizophrenia and in long-term maintenance. It showed better clinical efficacy in psychotic symptoms treatment than many first-generation antipsy- chotics [2]. Oral risperidone treatment showed a significant clinical out- come in reduction of autistic disorder associated irritability and other behavioral symptoms in children and adolescents main- tained for up to 6 months. The drug showed good tolerability, and Citation: Nagwa A Sabri., et al. “Development of a Novel Method for Determination of Risperidone in Pharmaceutical Products and its Quality Control Application". Acta Scientific Pharmaceutical Sciences 5.3 (2021): 101-109.