Title :
Analytical methodology to determine the potency and quality of misoprostol tablets
Author :
Carr, S.A. ; Darbyshire-Brown, A. ; Allen, Colin ; McCrossen, S.D. ; Brett, T.
Author_Institution :
Broughton Labs., Broughton, UK
Abstract :
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.
Keywords :
biochemistry; drugs; pharmaceutical technology; separation; analytical methodology; column temperature; degradation impurity; isocratic acetonitrile-water-methanol mobile phase; misoprostol tablet potency determination; misoprostol tablet quality determination; reversed phase HPLC method; separation; Misoprostol; assay; degradation products; high performance liquid chromatography; impurities;
Conference_Titel :
Appropriate Healthcare Technologies for Developing Countries, 7th International Conference on
Conference_Location :
London
Electronic_ISBN :
978-1-84919-680-2
DOI :
10.1049/cp.2012.1488
