The development of british jpharmacopoeia monographs for idoxuridine and idoxuridine eye drops using high-pressure liquid chromatography for essay and for controlling related impurities
✍ Scribed by G.P.R. Carr
- Publisher
- Elsevier Science
- Year
- 1978
- Tongue
- English
- Weight
- 908 KB
- Volume
- 157
- Category
- Article
- ISSN
- 1873-3778
No coin nor oath required. For personal study only.
✦ Synopsis
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.