Chromatographic Changes
Factor
Level
Retention time
Tailing factor
Flow Rate(mL/min)
CZ
6.12
6.11
6.14
6.13
± 0.2118
CZ
6.10
6.11
6.12
6.11
±0.2189
CZ
1.15
1.16
1.18
1.16
± 0.2412
CZ
1.17
1.15
1.16
1.16
±0.1446
0.9
–0.1
1.0
0
1.1
+0.1
Mean
S.D.
Mobile Phase(±1mL changing Acetonitrile : Methanol )
Level
59:39
– 1.0
60:40
0
61:41
+1.0
Mean
S.D.
Table 6:
Results of Robustness Studies