Chromatography Research International / 2013 / Article / Tab 8 / Research Article
Implementation of QbD Approach to the Analytical Method Development and Validation for the Estimation of Propafenone Hydrochloride in Tablet Dosage Form Table 8 Statistical data of Validation.
Parameters Method 1 Method 2 Method 3
250 247.4 nm 219.2 nm Linearity range 400–2400 ng 10–50 µg/mL 5–30 µg/mL Regression equation
Correlation coefficient (
) 0.99 0.99 0.99 % Recovery (
= 3) 100.2 100.07 100.4 LOD 35.4 ng 0.09 µg/mL 0.48 µg/mL LOQ 107.4 ng 0.27 µg/mL 1.44 µg/mL Molar absorptivity (lit/mole/cm) — 6537.84 13793.72 Sandell’s sensitivity (µg/sqcm/0.001) — 0.058 0.027 Precision (% R.S.D.) Intra-day (
= 3) 0.10 0.11 0.54 Inter-day (
= 3) 0.41 0.08 1.14 Standard error 0.168 × 10−3 2.65 × 10−4 2.38 × 10−3 Specificity (% R.S.D.) 0.55 0.57 0.28 Robustness (% R.S.D.) 0.19 0.84 0.57