Parameter

Temperature
(± 5°C of set temperature)

Flow rate
(± 0.1 ml/min of the set flow)

pH
(± 1 unit)

Variation

20°C

30°C

0.6 ml/min

0.8 ml/min

95%

105%

% RSD for 5
replicate injections

SS

1.3

1.2

1.4

1.1

1.2

1.2

NS

1.2

1.2

1.2

1.1

1.3

1.2

USP Resolution between

SS & NS

5.2

5.8

5.5

5.7

5.0

5.9

Table 5: Robustness Study