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. 2019 Sep 10;11(8):1358–1366. doi: 10.1080/19420862.2019.1658492

Table 1.

Variation in method output (RSD, %) as a function of robustness testing for a technique comprised of evaluating changes in stationary phase batches, DFA batches, LC systems, columns, temperature, mass load, flow rate, DFA concentration, and lifetime for the separation observed in Figure 3(c).

Variation in Method Output (RSD, %)
  Peak Capacity Percent Peak Area of Light Chain(0) Percent Peak Area of Fd′(3) Retention Time of Light Chain(0) Retention Time of Fd′(3) DAR
Stationary Phase Batches (3) 3.7 1.4 3.1 1.9 1.8 0.2
DFA Batches (3) 0.6 0.8 2.6 0.7 0.4 0.4
LC Systems (3 Systems, 9 Columns) 1.7 3.1 4.3 0.5 0.4 0.5
Temperature (±5%) 3.7 1 1.4 1.1 0.3 1.1
Mass Load (±5%) 0.9 0.4 1.9 0.2 0.2 0.2
Flow Rate (±5%) 0.7 0.2 0.8 1.1 0.8 0.1
Percent DFA (±5%) 4.7 2.7 4.6 2.0 0.9 0.9
Lifetime Study (1) 1.6 1.8 4.0 0.5 0.3 0.0
Lifetime Study (2) 0.3 0.2 1.2 0.7 0.8 0.4