- Title
- Stability indicating HPLC-ECD method for the analysis of clarithromycin in pharmaceutical dosage forms: Method scaling versus re-validation.
- Creator
- Makoni, Pedzisai A
- Creator
- Chikukwa, Mellisa
- Creator
- Khamanga, Sandile M
- Creator
- Walker, Roderick B
- Subject
- To be catalogued
- Date Issued
- 2019
- Date
- 2019
- Type
- text
- Type
- article
- Identifier
- http://hdl.handle.net/10962/183387
- Identifier
- vital:43984
- Identifier
- xlink:href="https://doi.org/10.3390/scipharm87040031"
- Description
- 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–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.
- Format
- computer
- Format
- online resource
- Format
- application/pdf
- Format
- 1 online resource (20 pages)
- Format
- Publisher
- MDPI
- Language
- English
- Relation
- Scientia Pharmaceutica
- Relation
- Makoni, P.A., Chikukwa, M.T., Khamanga, S.M. and Walker, R.B., 2019. Stability indicating HPLC-ECD method for the analysis of clarithromycin in pharmaceutical dosage forms: method scaling versus re-validation. Scientia Pharmaceutica, 87(4), p.31
- Relation
- Scientia Pharmaceutica volume 87 number 4 p. 31 2019 2218-0532
- Rights
- Publisher
- Rights
- Use of this resource is governed by the terms and conditions of the MDPI Open Access Statement (https://www.int-res.com/journals/terms-of-use/)
- Rights
- Open Access
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Collections
Walker, Roderick Bryan (Prof)
RU Department of Pharmacy
Khamanga, Sandile S M (Assoc Prof)
Makoni, Pedzisai A (Dr)
| Thumbnail | File | Description | Size | Format | |||
|---|---|---|---|---|---|---|---|
| View Details Download | SOURCE1 | Stability indicating HPLC-ECD method for the analysis of clarithromycin in pharmaceutical dosage forms method scaling versus re-validation.pdf | 1 MB | Adobe Acrobat PDF | View Details Download |