DEVELOPMENT AND VALIDATION OF REVERSE PHASE LIQUID CHROMATOGRAPHY METHOD FOR ESTIMATION OF ISOTRETINOIN (13-CIS RETINOIC ACID) IN PHARMACEUTICAL DOSAGE FORM

摘要

In the present study, a reverse phase high performance liquid chromatographic method was developed and validated for the determination of Isotretinoin in pharmaceutical dosage form. Chromatographic separation was carried out on a C-8 column using a mobile phase consisting of acetonitrile:isopropyl alcohol (50:50, v/v) adjusted at pH 5.0 using 1% ortho phosphoric acid. Flow rate was 1ml min?1 and UV detection was carried at 280 nm. Caffeine was used as an internal standard. The calibration curve was linear over the range 5–600μgml?1. R.S.D. for precision study was found to be <1%. The result of accuracy study was ranged between 98.61% and 101.51% with a R.S.D. lower than 2%. LOD and LOQ were found to be 0.0428μgml?1 and 0.1298μgml?1, respectively. The method was simple, rapid, easy to apply and very suitable for routine analysis of Isotretinoin in pharmaceutical dosage form.