Analytical methodology to determine the potency and quality of misoprostol tablets

A new reversed-phase HPLC method for determining the content of misoprostol and its related substances in misoprostol tablets has been developed. A Symmetry C18 5μm, 250×4.6 mm column and an isocratic acetonitrile/water/methanol mobile phase (45:55:1% v/v) at aflow rate of 1.0 ml/min gave adequate separation of misoprostol and its degradation impurities. The column temperature was maintained at 30 °C with UV detection at 200 nm. The method has been shown to be suitable for analysis of misoprostol tablets.