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Table 1 Optimization mobile phase and column in method development

From: A novel UPLC-PDA isocratic method for the quantification fulvestrant in oil-based pre-filled syringe injection matrix formulations

Trail no. Mobile phase composition Column Observation Inference
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