Table 10 Results of effect of variation in organic (acetonitrile) variation
S. No. | Name of the parameter | Water:ACN:MeOH (300:400:300) | Water:ACN:MeOH (300:360:300) | Water:ACN:MeOH (300:440:300) |
|---|---|---|---|---|
1 | Tailing factor for fulvestrant peak | 0.94 | 0.94 | 0.95 |
2 | % RSD of fulvestrant peak areas for five replicate injections of standard | 0.2 | 0.1 | 0.3 |
3 | USP plate count for fulvestrant peak | 4229 | 4263 | 4002 |
4 | % Assay | 101.4 | 100.7 | 100.7 |