| S. No | Validation Parameters | Acceptance Criteria | |
| 1.0 | System Suitability | ||
| % RSD | NMT 10.0 | ||
| 2.0 | Limit of Detection
(Signal to Noise Ratio) |
NLT 3:1 | |
| 3.0 | Limit of Quantification
(Signal to Noise ratio) |
NLT 10:1 | |
| 4.0 | Specificity | There should not be any interference between the responses of blank, sample and standard. | |
| 5.0 | Precision | ||
| 5.1 | System Precision | RSD NMT 10.0% | |
| 5.2 | Method Precision | RSD NMT 10.0% | |
| 5.3 | Intermediate Precision | Overall RSD NMT 10.0% | |
| 6.0 | Linearity | Coefficient Correlation NLT 0.99 | |
| 7.0 | Range
(Between 50 to 150 % of the specification limit) |
Linear | |
| 8.0 | Accuracy
(Individual Recovery) |
50 – 150 % | |
| 9.0 | Robustness | ||
| 9.1 | Dilution Integrity
(% RSD) |
NMT 15.0 % | |
| 9.2 | Stability
(% RSD) |
NMT 10.0 % | |
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