Validated UPLC method for the fast and sensitive determination of steroid residues in support of cleaning validation in formulation area.
An ultra performance liquid chromatographic (UPLC) method was developed for simultaneous determination of seven steroid (dienogest, finasteride, gestodene, levonorgestrel, estradiol, ethinylestradiol, and norethisterone acetate) active pharmaceutical ingredient (API) residues. A new, generic method is presented, with which it is possible to verify the cleaning process of a steroid producing equipment line used for the production of various pharmaceuticals. The UPLC method was validated using an UPLC BEH C18 column with a particle size of 1.7 microm (50 mm x 2.1 mm) and acetonitrile-water (48:52, v/v) as mobile phase at a flow rate of 0.55 ml/min. Method development and method validation for cleaning control analysis are described. The rapid UPLC method is suitable for cleaning control assays within good manufacturing practices (GMP) of the pharmaceutical industry.
Fekete
Szabolcs
S
Formulation Development, Chemical Works of Gedeon Richter Plc, Budapest X, Gyömroi út 19-21, Hungary. fekete.szabolcs1@chello.hu
Fekete
Jeno
J
Ganzler
Katalin
K
D002626:Chemistry, Pharmaceutical / Q000592:standards*; D002851:Chromatography, High Pressure Liquid; D004345:Drug Industry / Q000592:standards; D004350:Drug Residues / Q000032:analysis*; D007202:Indicators and Reagents; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D012996:Solutions; D012997:Solvents; D013056:Spectrophotometry, Ultraviolet; D013256:Steroids / Q000032:analysis*
D007202:Indicators and Reagents; D012996:Solutions; D012997:Solvents; D013256:Steroids