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Table 4 Predicted results and confidence intervals for the selected responses of the optimized method

From: Perspectives in modeling and model validation during analytical quality by design chromatographic method evaluation: a case study

Response

Goal

Predicted result

Desirability

− 2 Sigma conf. limit

+ 2 Sigma conf. limit

No. of peaks

Maximize

8.0

1.0000

6.3

10.5

No. of peaks ≥ 1.5 — USP resolution

Maximize

6.2

1.0000

4.8

9.5

Max peak 1 – USP plate count

Maximize

20,313

1.0000

17,560

23,067

Max peak 1 — USP plate count — Cpk

Maximize

2.01

1.0000

1.78

2.24

No. of peaks ≥ 1.5 — USP resolution — Cpk

Maximize

3.59

1.0000

3.54

3.63