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