Identification and characterization of major degradation products of risperidone in bulk drug and pharmaceutical
Rajesh Singh Tomar1, T J Joseph, A S R Murthy
1Analytical Development Laboratory, Torrent Research Center, Bhat, Gandhinagar, Gujarat 382428, India.
Abstract:
Acid, base and oxygen stability of risperidone, a novel anti-psychotic drug, has been evaluated storing the sample in solution phase. One of the major degradation products has been identified and characterized by using techniques namely IR, MS and NMR after isolation by preparative LC. The other major degradation product has been identified with help of MS/MS data and by co-eluting in analytical LC with the available standard. The effect of acid and base resulted in the formation of hydroxy risperidone and the effect of oxygen lead to the formation of N-oxide of risperidone. The two major degradation products in the dosage forms were also characterized as 9-hydroxy risperidone and N-oxide of risperidone, after enrichment through preparative LC, by LC-MS/MS and HPLC. Structural elucidation of degradation product leading to the formation of N-oxide of risperidone is discussed in detail.
More Related Videos
10:17High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
Published on: April 23, 2019
10:33Development of Inhibitors of Protein-protein Interactions through REPLACE: Application to the Design and Development Non-ATP Competitive CDK Inhibitors
Published on: October 26, 2015
Related Concept Videos
Drug Dissolution: Requirements and Profile Comparison
Clinically Relevant Drug Product Specifications: Methods of Establishment
Drug Product Stability
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
Modified-Release Drug Delivery Systems: Bioavailability
