Stability-Indicating HPLC Method for Quantification of Celecoxib and Diacerein Along With Its Impurities in Capsule Dosage Form
| Autor: | R Satyanarayana Murthy, Ravi Kumar Maram, Hanimi Reddy Bapatu |
|---|---|
| Rok vydání: | 2014 |
| Předmět: |
Detection limit
Chromatography Reverse-Phase Sulfonamides Chromatography Chemistry Elution Anthraquinones Capsules General Medicine Capsule Dosage Form High-performance liquid chromatography Dosage form Analytical Chemistry chemistry.chemical_compound Drug Stability Celecoxib Impurity medicine Pyrazoles Methanol Diacerein Drug Contamination Chromatography High Pressure Liquid medicine.drug |
| Zdroj: | Journal of Chromatographic Science. 53:144-153 |
| ISSN: | 1945-239X 0021-9665 |
| DOI: | 10.1093/chromsci/bmu031 |
| Popis: | A novel stability-indicating reverse phase high performance liquid chromatography method was developed and validated for the simultaneous determination of Celecoxib (CEL) and Diacerein (DIN) and its impurities in capsule dosage form. The method was developed using L1 column with gradient using the mobile phase consist of Solution A (pH = 2.3 buffer) and Solution B (methanol and acetonitrile; 50 : 50, v/v). The eluted compounds were monitored at 255 nm. CEL and DIN were subjected to oxidative, acid, base, hydrolytic, thermal and photolytic stress conditions. The developed method was validated as per International Conference on Harmonisation guidelines with respect to specificity, linearity, limit of detection, limit of quantitation, accuracy, precision and robustness. The limit of quantitation results were ranged from 0.07 to 0.09 µg/mL for CEL impurities and 0.052 to 0.065 µg/mL for DIN impurities. This method is suitable for the estimation of impurities and assay of CEL and DIN in capsules dosage forms. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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