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Table 25 Robustness study results of ethyl acetate

From: Determination of residual solvents in paclitaxel by headspace gas chromatography

Parameter

System conditions

Percentage RSD for peak area (n = 6)

Retention time

Plate count

Tailing factor

Flow rate (± 0.2 mL/min)

2.3

1.8

15.17

66574

1.2

2.5

1.7

13.79

65848

1.1

2.7

1.9

12.41

67418

1.1

Column oven temperature (± 5 °C)

35 °C

1.8

15.18

64217

1.3

40 °C

1.7

13.79

65848

1.1

45 °C

1.6

12.43

66412

1.2

Vial oven temperature (± 5 °C)

85 °C

1.7

13.76

64718

1.3

90 °C

1.7

13.79

65848

1.1

95 °C

1.8

13.77

63241

1.2