Table 2.
Linearity data of tenofovir calibration sets
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---|---|---|---|---|---|
Standard curve | Range (µg/mL) | Calibrators | Slope | y-Intercept | R2 value |
Validation 1 | 1.0–10 | 6 | 0.0566 | −0.0691 | 0.9995 |
Validation 2 | 1.0–10 | 6 | 0.0579 | −0.0948 | 0.9996 |
Validation 3 | 1.0–10 | 6 | 0.0603 | −0.0166 | 0.9995 |
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Accuracy and precision: drug substance (n = 6)
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Validation parameters | Validation solutions | 1 µg/mL | 2 µg/mL | 6 µg/mL | 10 µg/mL |
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Accuracy (%) | Set 1 | 94.6 | 96.8 | 101.2 | 99.4 |
Set 2 | 95.5 | 98.6 | 100.0 | 99.5 | |
Set 3 | 98.0 | 99.1 | 100.7 | 99.8 | |
Precision (%RSD) | Set 1 | 2.58 | 1.51 | 0.625 | 1.15 |
Set 2 | 0.84 | 1.17 | 0.334 | 0.49 | |
Set 3 | 0.98 | 1.61 | 0.72 | 1.70 |
Abbreviation: RSD, relative standard deviation.