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RP-HPLC Estimation of Risperidone in Tablet Dosage Forms.

S L Baldania¹, K K Bhatt, R S Mehta

¹Anand Pharmacy College, Opp. Town Hall, Shri Ramkrishna Seva Mandal Campus, Anand-388 001, India.

Indian Journal of Pharmaceutical Sciences

|January 5, 2010

Summary

A new reverse phase liquid chromatographic method accurately estimates risperidone in tablets. This validated analytical technique ensures reliable quantification of risperidone in pharmaceutical formulations.

Keywords:

RP-HPLC Reverse phase liquid chromatography risperidone specificity validation

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Area of Science:

Analytical Chemistry
Pharmaceutical Analysis

Background:

Accurate quantification of active pharmaceutical ingredients (APIs) is crucial for drug quality control.
Risperidone is an atypical antipsychotic used to treat schizophrenia and bipolar disorder.
Validated analytical methods are essential for ensuring the safety and efficacy of risperidone formulations.

Purpose of the Study:

To develop and validate a simple, specific, accurate, and precise reverse phase liquid chromatographic (RP-LC) method.
To enable the quantitative determination of risperidone in tablet dosage forms.

Main Methods:

Utilized a Phenomenex Gemini C-18 column with a mobile phase of methanol:acetonitrile:potassium dihydrogen orthophosphate.
Employed isocratic elution at a flow rate of 1.3 ml/min and monitored effluents at 234 nm.
Validated the method for linearity, accuracy, precision, specificity, limit of quantification, limit of detection, robustness, and stability, using clozapine as an internal standard.

Main Results:

The method demonstrated excellent linearity, accuracy, and precision for risperidone estimation.
The limit of detection (LOD) was 500 ng/ml and the limit of quantification (LOQ) was 990 ng/ml.
High recovery rates (99.02-101.68%) confirmed the method's accuracy for risperidone in tablet formulations.

Conclusions:

The developed RP-LC method is simple, specific, accurate, and precise for risperidone estimation.
The method is successfully validated and applicable for the quantitative determination of risperidone in tablet formulations.
This validated method contributes to robust quality control of risperidone drug products.