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

Journal of Analytical Science and Technology

Table 2 Stress conditions for fulvestrant

Nature of stress	Condition	% Assay of stressed test	Purity angle	Purity threshold	Purity flag
Unstressed	NA	100.4	1.991	2.948	NO
Acid	2 N HCl@ RT, 18 h	104.0	2.255	3.206	NO
Base	2 N NaOH@ RT, for 18 h	100.5	1.809	2.658	NO
Peroxide	30% H₂O₂@ 70 °C, for 18 h	102.4	2.028	3.170	NO
Water	70 °C for 18 h	91.3	2.119	3.098	NO
Photolytic	1200 W/m² 200 million lux hours	101.6	0.134	5.329	NO
Thermal	70 °C for 18 h	97.0	2.060	2.985	NO
Humidity	90% RH for 7 days	102.8	0.143	5.336	NO
Metallic ion	0.05 M CuSo4 @ 10 min	99.0	0.475	8.427	NO