Development and Validation of a Stability-Indicating HPLC Method for the Simultaneous Determination of trans-Resveratrol and cis-Resveratrol in an Injectable Solution
Table 1
Summary of validation parameters of t-RSV.
Parameter
Acceptance requirements
r (>0.998)
r2 (>0.995)
% recoveryA (98–102%)
% RSD (<2.0)
IC (β0) includes 0
IC (β1) includes 1
|di| (<2)
Linearity of the systemB
0.999
0.998
1.39
−4729.09 at 1448.42
Accuracy and precisionC
100.16 ± 1.47
1.47
−0.001 at 0.25
0.93 at 1.00
Linearity of the methodC
0.999
0.998
100.11 ± 1.20
1.19
−0.06 at 0.23
0.94 at 1.02
Robustness
Mobile phase composition (FA/ACN)
69/31 v/v
100.36 ± 0.51
0.51
0.32
71/29 v/v
99.89 ± 0.38
0.39
0.16
pH of FA
pH = 3
100.00 ± 0.81
0.81
0.00
pH = 5
100.00 ± 0.35
0.35
0.00
Changing equipment
UPLC
100.01 ± 0.24
0.24
0.01
r = correlation coefficient; r2 = determination coefficient; IC (β0) = y-intercept confidence interval; % RSD = relative standard deviation; IC (β1) = slope confidence interval; |di| = absolute difference. AMean % recovery ± standard deviation; B = standards; C = fortified samples. Acceptance requirements are not required for the validation parameter.
