title: The development of British pharmacopoeia monographs for idoxuridine and idoxuridine eye drops using high-pressure liquid chromatography for assay and for controlling related impurities.
abstract: The monograph published in the 1973 edition of the British Pharmacopoeia (BP) for idoxuridine required revision because it contained a non-specific assay and no tests for related impurities. It was also necessary to prepare a new monograph for idoxuridine eye drops. The Japanese Pharmacopoeia contains a thin-layer chromatographic test for impurities but this was not considered ideal. Improved thin-layer chromatographic tests were sought but when this was unsuccessful, methods using high-pressure liquid chromatography were examined. A system using reversed-phase chromatography was selected for inclusion in BP Addendum 1977 since it provided a specific assay method and limit test for related impurities which could be applied to both the drug substance and the eye drops.
mesh_terms: D002845:Chromatography / Q000379:methods; D004304:Dosage Forms; D004340:Drug Contamination; D006801:Humans; D007065:Idoxuridine / Q000032:analysis* / Q000592:standards; D009883:Ophthalmic Solutions / Q000032:analysis* / Q000592:standards; D010602:Pharmacopoeias as Topic; D006113:United Kingdom
chemical_list: D004304:Dosage Forms; D009883:Ophthalmic Solutions; D007065:Idoxuridine