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Validated HPLC method for the determination of ranitidine in plasma
A Castro1, A Arancibia, P Romero
1Department of Sciences and Pharmaceutical Technology, Faculty of Chemical and Pharmaceutical Sciences, University of Chile, Santiago, Chile.
Die Pharmazie
|November 12, 2003
Summary
A validated HPLC method accurately quantifies ranitidine in human plasma using sulfanilamide as an internal standard. This reliable assay is suitable for bioavailability studies, ensuring precise drug level determination.
Area of Science:
- Analytical Chemistry
- Pharmacokinetics
Background:
- Accurate quantification of ranitidine in biological matrices is crucial for pharmacokinetic and bioavailability studies.
- Existing analytical methods may lack the sensitivity, specificity, or validation required for regulatory compliance.
Purpose of the Study:
- To develop and validate a high-performance liquid chromatography (HPLC) method for the determination of ranitidine in human plasma.
- To ensure the method meets Food and Drug Administration (FDA) bioanalytical validation criteria.
Main Methods:
- High-performance liquid chromatography (HPLC) with UV detection at 300 nm.
- Solid-phase extraction (SPE) for plasma sample purification using a copolymeric column.
- Sulfanilamide as an internal standard (IS) for quantitative analysis.
Main Results:
- The method demonstrated linearity between 100-1600 ng/ml with a limit of quantitation of 100 ng/ml.
- Recovery exceeded 94%, with accuracy, precision, and selectivity meeting bioanalytical validation recommendations.
- The method was successfully applied in a ranitidine tablet bioavailability study.
Conclusions:
- A robust and validated HPLC method for ranitidine determination in human plasma has been established.
- This method is suitable for use in pharmacokinetic and bioavailability studies, adhering to regulatory standards.
