Developing New Criteria for Validity Evaluation of Analytical Methods

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis
• Chemical Sciences

Background:

• Analytical method validation is crucial for accurate chemical substance determination.
• Invalid methods yield incorrect data, impacting pharmaceutical, food, and medical sciences.
• Existing validation guidelines are comprehensive but can be enhanced.

Purpose of the Study:

• To propose novel criteria for evaluating analytical method validity.
• Focus on upper and lower limits of the linear range and calibration curve responses.
• Enhance detection of invalid analytical methods.

Main Methods:

• Analysis of 150 reported analytical methods (separation and non-separation techniques).
• Evaluation of chemical and pharmaceutical compounds (organic and inorganic).
• Comparison of coefficient of determination (R²) with new criteria.

Main Results:

• Coefficient of determination (R²) alone can lead to inaccurate linear range and validation.
• Only 55% of analyzed methods were deemed valid using traditional approaches.
• Proposed criteria offer a more robust assessment of method validity.

Conclusions:

• Established criteria using calibration curve equations and linear range are effective.
• The new criteria are suitable for assessing the validity of analytical methods.
• Improved method validation leads to more reliable scientific data.