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Table 11 Robustness results for (1S,2R-enantiomer) impurity

From: Determination of enantiomer impurity in Bortezomib lyo injection formulation by using normal-phase liquid chromatography

Parameter

Altered

S/N

Resolution

Tailing factor

% RSD

Condition

As such condition (method precision)

69

3.9

1.33

0.8

Flow variation

Low flow

51

3.5

1.39

0.6

(0.6 mL/min)

(0.5 mL/min)

 

High flow

52

3.8

1.32

0.8

 

(0.7 mL/min)

Temperature variation (25 °C)

Low Temperature 20 °C

60

3.5

1.35

0.6

High Temperature 30 °C

73

4.7

1.33

0.6

Mobile phase

Composition variation (IPA)

Low variation

53

3.8

1.35

0.3

n-Heptane: isopropyl alcohol: ethanol: trifluoroacetic acid-(820:150:30:1) v/v/v/v

n-Heptane: isopropyl alcohol: ethanol: trifluoroacetic acid-(835:135:30:1) v/v/v/v

High variation

79

4.2

1.36

0.4

n-Heptane: isopropyl alcohol: ethanol: trifluoroacetic acid-(805:165:30:1) v/v/v/v

Mobile phase

Composition variation (ethanol)

Low variation

73

4.1

1.39

0.8

n-Heptane: isopropyl alcohol: ethanol: trifluoroacetic acid-(823:150:27:1) v/v/v/v

High variation

65

4.3

1.41

0.6

n-Heptane: isopropyl alcohol: ethanol: trifluoroacetic acid-(817:150:33:1) v/v/v/v