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
𝜆max	250	247.4 nm	219.2 nm
Linearity range	400–2400 ng	10–50 µg/mL	5–30 µg/mL
Regression equation	𝑌=0.339𝑋+0.131	𝑌=0.019𝑋+0.0544	𝑌=0.029𝑋+0.035
Correlation coefficient (𝑅^2)	0.99	0.99	0.99
% Recovery (𝑛 = 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 (𝑛 = 3)	0.10	0.11	0.54
Inter-day (𝑛 = 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