Stability Indicating Reversed-Phase High Performance Liquid Chromatography Method for Determination of Impurities in Ofloxacin Tablet Formulations
| Autor: | Avvaru Praveen Kumar, Mohinish Sahai, Bobba Venkateswara Reddy, J. Sreeramulu, Jung Hag Park, Gosula Venkat Ram Reddy |
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| Rok vydání: | 2010 |
| Předmět: |
Detection limit
Chromatography Biochemistry (medical) Clinical Biochemistry Hydrochloric acid Reversed-phase chromatography Biochemistry High-performance liquid chromatography Dosage form Analytical Chemistry Hydrolysis chemistry.chemical_compound chemistry Sodium hydroxide Forced degradation Electrochemistry Spectroscopy |
| Zdroj: | Analytical Letters. 43:2653-2662 |
| ISSN: | 1532-236X 0003-2719 |
| DOI: | 10.1080/00032711003731423 |
| Popis: | A gradient reversed-phase high performance liquid chromatography (RP-HPLC) method was developed for separation and quantitation of impurities in pharmaceutical dosage form of ofloxacin tablets. The developed method was a stability indicating test method for estimation of related impurities generated during synthesis, formulation, and storage of ofloxacin tablets. Forced degradation studies were performed on ofloxacin tablets including acid hydrolysis (5.0 M hydrochloric acid), base hydrolysis (5.0 M sodium hydroxide), oxidation (30% hydrogen peroxide), heat (105°C) humidity degradation 25°C/92% RH/119 b & 40 min, and photolytic degradation (2600 Lux/119 h & 40 min). From the degradation study, the degradation was found between 0–15%. Limit of detection and limit of quantification were established in terms of percentage for all potential impurities. The recovery studies were conducted on finished dosage samples (tablets) for all potential impurities and the average percentage recovery was ranged from 90.8 ... |
| Databáze: | OpenAIRE |
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