Stability Indicating HPLC-ECD Method for the Analysis of Clarithromycin in Pharmaceutical Dosage Forms: Method Scaling versus Re-Validation
| Autor: | Sandile M M Khamanga, Pedzisai A. Makoni, Mellisa T R Chikukwa, Roderick B. Walker |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Chromatography
Central composite design Resolution (mass spectrometry) 010401 analytical chemistry lcsh:RS1-441 Pharmaceutical Science method validation Electrochemical detection clarithromycin 030226 pharmacology & pharmacy 01 natural sciences Dosage form 0104 chemical sciences lcsh:Pharmacy and materia medica 03 medical and health sciences 0302 clinical medicine Stability indicating electrochemical detection USP method scaling Response surface methodology central composite design stability-indicating Scaling Hplc ecd Mathematics |
| Zdroj: | Scientia Pharmaceutica Volume 87 Issue 4 Scientia Pharmaceutica, Vol 87, Iss 4, p 31 (2019) |
| ISSN: | 2218-0532 |
| DOI: | 10.3390/scipharm87040031 |
| Popis: | An isocratic high-performance liquid chromatographic method using electrochemical detection (HPLC-ECD) for the quantitation of clarithromycin (CLA) was developed using Response Surface Methodology (RSM) based on a Central Composite Design (CCD). The method was validated using International Conference on Harmonization (ICH) guidelines with an analytical run time of 20 min. Method re-validation following a change in analytical column was successful in reducing the analytical run time to 13 min, decreasing solvent consumption thus facilitating environmental and financial sustainability. The applicability of using the United States Pharmacopeia (USP) method scaling approach in place of method re-validation using a column with a different L&ndash designation to the original analytical column, was investigated. The scaled method met all USP system suitability requirements for resolution, tailing factor and % relative standard deviation (RSD). The re-validated and scaled method was successfully used to resolve CLA from manufacturing excipients in commercially available dosage forms. Although USP method scaling is only permitted for columns within the same L-designation, these data suggest that it may also be applicable to columns of different designation. |
| Databáze: | OpenAIRE |
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