Abstract:The gradient HPLC method was developed to detect and quantify four related substances (FIP, FHO-2, STG-01, and desfluoro) in ezetimibe drug material. The efficient separation was carried out on Water X-Select CSH C18 column (4.6 mm × 100 mm, 2.5 μm). The impurities were separated in gradient mode of elution with 0.1% trifluoroacetic acid in water (mobile phase A) and 0.1% trifluoroacetic acid in acetonitrile (mobile phase B) at a flow rate of 1.0 ml /min. The effluents were detected at 254 nm. The method has b… Show more
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