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. 2015 Mar 24;2015:806736. doi: 10.1155/2015/806736

Table 3.

Validation parameters of formulations F1–F5.

F1 F2 F3 F4 F5 Criterion
SOT SORB SOT SORB SOT SORB SOT SORB SOT SORB
Repeatability t R (% R.S.D.)a 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 X < 1%
Repeatability area (% R.S.D.)a 0.22 0.57 0.22 0.57 0.22 0.57 0.22 0.57 0.22 0.57 X < 1%
Theoretical plates per meter 11,810 282,650 11,810 282,650 11,810 282,650 11,810 282,650 11,810 282,650
Resolutiona 18.39 18.39 18.39 18.39 18.39 R ij > 1.5
Tailing factora 1.10 1.23 1.10 1.23 1.10 1.23 1.10 1.23 1.10 1.23 T = 0.8–1.5
Precision (% R.S.D.)b 0.43 0.16 0.49 0.98 0.26 1.51 0.21 1.11 X < 5%
Linearity (correlation coefficient)c 0.9995 0.9995 0.9995 0.9995 0.9995 0.9995 0.9995 0.9995 0.9995 0.9995 R > 0.9990
Accuracy recovery (%)b 101.09 99.57 99.59 98.26 99.93 98.70 99.35 98.57 X = 100 ± 5%
Accuracy (% R.S.D.)b 0.58 0.85 1.44 2.27 0.71 2.07 0.57 1.14 X < 5%
Selectivity No interference No interference No interference No interference No interference No interference

aSix injections.

bSix samples, three injections of each sample.

cAt 50, 75, 100, 134, 166, and 200% concentration levels.

SOT: sotalol hydrochloride.

SORB: potassium sorbate.

Fx: formulations with various excipients.

% R.S.D.: relative standard deviation in %.