We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Green micellar stability‐indicating high‐performance liquid chromatography method for determination of rupatadine fumarate in the presence of its main impurity desloratadine: Oxidative degradation kinetics study.
- Authors
Amer, Mona M.; Habib, Ahmed A.; Hammad, Sherin F.; Kamal, Amira H.
- Abstract
A green micellar stability‐indicating high‐performance liquid chromatography method was developed for rupatadine fumarate determination in existence with its main impurity desloratadine. Separation was attained using Hypersil ODS column (150 × 4.6 mm, 5 μm), the micellar mobile phase consisted of 0.13 M sodium dodecyl sulfate, 0.1 M disodium hydrogen phosphate adjusted by phosphoric acid to pH 2.8 and 10% n‐butanol. The column was maintained at 45◦C and detection was carried out at 267 nm. A linear response was achieved over the range of 2–160 μg/ml for rupatadine and 0.4–8 μg/ml for desloratadine. The method was applied for rupatadine determination in alergoliber tablets and alergoliber syrup without the interference of methyl paraben and propyl paraben present as main excipients. Rupatadine fumarate revealed pronounced susceptibility to oxidation; further study of oxidative degradation kinetics was carried out. Rupatadine was found to follow pseudo‐first‐order kinetics when exposed to 10% H2O2 at 60 and 80°C and the activation energy was found to be 15.69 Kcal/mol. At a lower temperature (40°C), degradation kinetics regression was best fitted as a polynomial quadratic relationship, thus rupatadine oxidation at a lower temperature tends to adopt a second‐order kinetics rate. Oxidative degradation product structure was revealed using infrared and found to be rupatadine N‐oxide at all temperature values.
- Subjects
MICELLAR liquid chromatography; HIGH performance liquid chromatography; SODIUM dodecyl sulfate; ACTIVATION energy; LOW temperatures; PHOSPHORIC acid
- Publication
Journal of Separation Science, 2023, Vol 46, Issue 14, p1
- ISSN
1615-9306
- Publication type
Article
- DOI
10.1002/jssc.202300135