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The validation criteria for analytical methods used in pharmacy practice research.
1Department of Pharmacy, General Infirmary, Leeds, Yorkshire, U.K.
Journal of Clinical Pharmacy and Therapeutics
|December 1, 1989
Summary
Analytical method validation is crucial for accurate drug determination in biological samples. This paper clarifies validation nomenclature and outlines procedures for methods used in drug analysis.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
- Method Development
Background:
- Method validation is a critical but often overlooked step in analytical method development.
- Ensuring the reliability of analytical methods is paramount before their application to real-world samples.
Purpose of the Study:
- To clarify the nomenclature surrounding analytical method validation.
- To describe the validation procedure for analytical methods.
- To focus on methods for determining drugs in biological fluids and formulations.
Main Methods:
- Literature review and synthesis of validation concepts.
- Description of a systematic approach to analytical method validation.
- Application of validation principles to drug analysis in biological matrices.
Main Results:
- A clear definition and understanding of method validation terminology.
- A structured procedure for validating analytical methods.
- Guidelines for validating methods used in pharmaceutical and biological analysis.
Conclusions:
- Method validation is indispensable for reliable analytical results.
- Standardized nomenclature and procedures enhance the quality of method validation.
- Proper validation ensures the suitability of analytical methods for their intended purpose in drug analysis.