Sensitive chemiluminescence assay for risperidone in pharmaceutical preparations

Area of Science:

• Analytical Chemistry
• Forensic Chemistry
• Pharmaceutical Analysis

Background:

• Accurate quantification of antipsychotic drugs like risperidone (RSP) is crucial for therapeutic drug monitoring and quality control.
• Existing analytical methods may lack the sensitivity, selectivity, or speed required for routine pharmaceutical analysis.
• Chemiluminescence (CL) offers a sensitive detection principle for trace-level analyte determination.

Purpose of the Study:

• To develop and validate a sensitive chemiluminescence (CL) method for the determination of risperidone (RSP).
• To utilize the catalytic effect of RSP on a luminol-hydrogen peroxide reaction for enhanced CL signal.
• To apply the developed method for the analysis of RSP in pharmaceutical formulations.

Main Methods:

• A flow system was employed for the CL reaction between luminol and hydrogen peroxide.
• The catalytic effect of risperidone (RSP) on the CL intensity was investigated.
• Calibration curves were generated, and method validation parameters including sensitivity, selectivity, and precision were assessed.
• The method was applied to the analysis of RSP in real pharmaceutical samples.

Main Results:

• The CL intensity showed a strong correlation with RSP concentration in the range of 10 pg/mL to 1.0 ng/mL.
• A low limit of detection (LOD) of 4 pg/mL (3 sigma) was achieved, indicating high sensitivity.
• The method demonstrated excellent selectivity and a high throughput of 120 samples per hour.
• Relative standard deviation was consistently below 5.0% (n=5), demonstrating good precision.

Conclusions:

• The proposed flow-injection CL method is highly sensitive and selective for risperidone (RSP) determination.
• The method is suitable for the rapid and accurate quantification of RSP in pharmaceutical preparations.
• This CL assay offers a valuable analytical tool for quality control and therapeutic drug monitoring of risperidone.