Development and Validation of a Stability Indicating RP-UPLC Method for Determination of Quetiapine in Pharmaceutical Dosage Form
2011

Development of a Fast Method to Measure Quetiapine in Medicines

Sample size: 6 publication 10 minutes Evidence: high

Author Information

Author(s): Trivedi Rakshit Kanubhai, Patel Mukesh C.

Primary Institution: Dr. Reddy’s Laboratories Ltd.

Hypothesis

A new RP-UPLC method can effectively separate and quantify quetiapine and its impurities in pharmaceutical dosage forms.

Conclusion

The developed RP-UPLC method is selective, precise, accurate, and stability-indicating for quetiapine in pharmaceutical dosage forms.

Supporting Evidence

  • The method was validated according to ICH guidelines for system suitability, specificity, precision, accuracy, linearity, robustness, and filter compatibility.
  • The method achieved a run time of only 5 minutes for a single analysis.
  • Significant degradation of quetiapine was observed under oxidative conditions, confirming the method's stability-indicating capability.
  • The average assay of quetiapine was found to be 99.9% with a relative standard deviation of 0.38%, indicating high precision.

Takeaway

Researchers created a quick and reliable way to test a medicine called quetiapine, making it easier to check if it's safe and effective.

Methodology

The method involved reversed phase ultra performance liquid chromatography (RP-UPLC) with gradient elution to separate quetiapine from its impurities.

Limitations

The method may not be applicable to all pharmaceutical formulations of quetiapine as it was specifically validated for solid dosage forms.

Digital Object Identifier (DOI)

10.3797/scipharm.1009-12

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