|
1
|
Monobasic sodium phosphate: acetonitrile (60:40 v/v)
|
ACQUITY UPLC HSST3 100 mm × 1 mm 1.8 μm
|
Delta (6,7) fulvestrant impurity not separated from fulvestrant
|
Method rejected
|
|
2
|
0.1% v/v TEA: acetonitrile (60:40 v/v)
|
ACQUITY UPLC HSST3 100 mm × 1 mm 1.8 μm
|
Impurities are not separated from fulvestrant peak
|
Method rejected
|
|
3
|
0.1% v/v OPA: methanol (600:400 v/v/v)
|
ACQUITY UPLC Phenyl 150 mm × 2.1 mm 1.7 μm
|
Impurities are separated from fulvestrant. But sulfone impurity was eluted very late
|
Method rejected
|
|
4
|
0.1% v/v OPA: acetonitrile: methanol (300:400:300 v/v/v)
|
ACQUITY UPLC Phenyl 150 mm × 2.1 mm 1.7 μm
|
Impurities are not well separated from fulvestrant
|
Method rejected
|
|
5
|
0.1% v/v OPA: acetonitrile and methanol (300;400;300 v/v/v)
|
BEH shield RP18, 50 mm × 2.1 mm 1.7 μm
|
Impurities are well separated from fulvestrant with good peak shape and less run time
|
Approved
|
