Drug substance The proposed UPLC Authentic sample Derivative synchronous spectroscopy FDSFS Reference methodb
Meana ±a SD 98.55 ± 0.78 98.32 ± 0.66 99.72 ± 1.32
t-test 1.77 2.18 2.23c
F-value 2.86 4.00 6.2c
aMean of seven and five determination of the proposed and reference methods.
An HPLC method using a cyano column with gradient flow and two mobile phase components :(component A) methanol: buffer (3:17 v/v), (component B) methanol : buffer (3:1 v/v), UV detection at 210 nm (24)
cThe theoretical values of t and F at P=0.05
Table 4: Statistical comparison between the proposed and the reference method for the determination of atomoxetine HCl in drug substance.