A systematic approach for reversed phase liquid chromatographic method development of fingolimod hydrochloride via design augmentation
| Autor: | Hariram Balasubramanian, Katkam Srinivas, Ramdoss Suresh Kumar, Srinivasu K. Mullapudi, Rajeswar Reddy Sagyam, Kalyanaraman Lakshminarayanan |
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| Rok vydání: | 2015 |
| Předmět: |
Aqueous solution
Chromatography Chemistry(all) Chemistry General Chemical Engineering LC method development General Chemistry Fingolimod and related substances Dosage form lcsh:Chemistry chemistry.chemical_compound Stability indicating lcsh:QD1-999 Fingolimod Hydrochloride Phase (matter) DoE HPLC & UHPLC Chemical Engineering(all) Degradation (geology) Ammonium Acetonitrile |
| Zdroj: | Arabian Journal of Chemistry, Vol 12, Iss 8, Pp 3289-3301 (2019) |
| ISSN: | 1878-5352 |
| DOI: | 10.1016/j.arabjc.2015.08.012 |
| Popis: | A stability indicating reversed phase liquid chromatographic (RP-LC) method was developed for the analysis of fingolimod hydrochloride (FIM) and its related compounds in drug substance and its dosage form. Separation of seven related compounds and three degradation products was achieved in a C18 stationary phase with 3 mM tetrabutyl ammonium hydrogen sulfate in 0.02% orthophosphoric acid and acetonitrile in gradient elution. Aqueous mobile phase components and column temperature were optimized through Design of experiments (DoE) for a fixed gradient program. Major degradation products were identified by LC-MS and degradation pathway is proposed. The validation results indicated that the method is sensitive in detection, linear, precise and accurate. The developed method was also demonstrated in UHPLC. Keywords: LC method development, Stability indicating, DoE, HPLC & UHPLC, Fingolimod and related substances |
| Databáze: | OpenAIRE |
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