As. Low et J. Wangboonskul, An HPLC assay for the determination of ketoconazole in common pharmaceutical preparations, ANALYST, 124(11), 1999, pp. 1589-1593
An HPLC method is described using octadecylsilica (3 mu m) with an acetonit
rile phosphate buffer mobile phase containing diethylamine which is capable
of separating ketoconazole [(+/-)-cis-1-acetyl-4-(4{[2-(dichlorophenyl)-2-
(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazine] from
four related compounds, (R049223, R063600, R053165 and R039519) and from e
xcipients in tablets, cream and shampoo. The method was validated using an
external calibration method for tablets, shampoo and creams and a standard
addition method for cream. The limits of detection for the related compound
s in the presence of ketoconazole are also reported.