Table 9 Results of effect of variation in organic (methanol) variation
S. No. | Name of the parameter | Water:ACN:MeOH (300:400:300) | Water:ACN:MeOH (300:400:270) | Water:ACN:MeOH (300:400:330) |
|---|---|---|---|---|
1 | Tailing factor for fulvestrant peak | 0.95 | 0.95 | 0.95 |
2 | % RSD of fulvestrant peak areas for five replicate injections of standard | 0.1 | 0.0 | 0.1 |
3 | USP plate count for fulvestrant peak | 4223 | 4288 | 3796 |
4 | % Assay | 98.0 | 97.6 | 97.6 |