Precision and repeatability: within-run and between-run variability of the method. Acceptance criterion is typically a relative standard deviation of ≤2% for area measurements.
Why one laboratory's 98.4% and another's 96.1% may not contradict
I read post #5 twice before replying, because I had assumed the opposite.
Robustness: the method gives consistent results when minor parameters vary. Tested by deliberately varying pH, temperature, flow rate, and mobile phase composition within reasonable ranges and demonstrating that results stay within acceptance.
On post #12 — agreed on the reasoning, with one qualification.
Limits of detection and quantitation: LOD is the lowest concentration that produces a signal above background. LOQ is the lowest concentration at which the method meets precision and accuracy acceptance criteria. Both are determined empirically.
Stability-indicating method: one that can separate a compound from its degradation products. Critical for assay methods that claim to measure actual degradation (as opposed to purity, which is orthogonal).
Forced degradation studies: deliberately stress the material with acid, base, oxidant, heat, light to generate degradation products and demonstrate that the method can separate them from the parent peak. Acceptance is that the method is stability-indicating.
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This topic was referenced in
- Specificity, linearity, accuracy, precision, range, robustness — with real criteriaAnalytics › Method validation · 48 replies
- Forced degradation studies: designing one that is informativeAnalytics › Method validation · 106 replies
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