چکیده (انگلیسی):

A simple, rapid, sensitive and accurate HPLC–UV detection method was developed and
validated for the determination of isotretinoin in human plasma. The method involves protein precipitation
of plasma by acetonitrile using nifedipine as the internal standard (IS). Chromatographic
separation was achieved on Agilent C18 column using an acetonitrile: aqueous 0.5% glacial acetic
acid (70:30, v/v) mobile phase. Isotretinoin in the eluent was monitored at 350 nm. Inter-assay of
the coefficient of variations (CV%) over the range of plasma calibration curves (0.02–0.60 lg/ml)
ranged from 2.32% to 6.49% with good correlation coefficient (R2 =0.999). The average recovery
of the extraction procedure was 99.128%. The LLOD and LLOQ are 0.007 and 0.02 lg/ml, respectively.
This method was applied for pharmacokinetic study and the results indicated that this
method is suitable for pharmacokinetic and bioavailability studies.