| An LC method for the simultaneous screening of some common counterfeit and sub-standard antibiotics Validation and uncertainty estimation. | |
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MedLine Citation:
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PMID: 18243626 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Pharmaceutical counterfeiting is a worldwide public health problem, often under-recognised, especially in developing countries where the percentage of counterfeit and sub-standard medicines is dramatically high. Antibiotics, among the most widespread drugs, have been particularly targeted by counterfeiters. World Health Organization emphasizes the need for development and distribution of screening methods explicitly targeted to counterfeit drugs. In this paper is presented a single method for the simultaneous analysis of some of the most common and counterfeited essential antibiotics: ampicillin, amoxicillin+clavulanic acid, doxycycline, cloxacillin, chloramphenicol. A full validation was performed in terms of linearity, precision, robustness and trueness; an assessment of uncertainty was carried out exploiting these data. A wide linearity range was investigated considering the specific nature of counterfeit and sub-standard drugs, whose content in active substance may be rather far from the declared amount. A large span in robustness parameters was considered and a complete intermediate precision assessment was conducted, envisaging the possibility of transferring the method to quality control laboratories, hopefully in developing countries. Finally, the method was successfully applied to the analysis of antibiotics purchased on the informal market in Chad, among which counterfeit and sub-standard samples were detected. |
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Authors:
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M C Gaudiano; A Di Maggio; E Antoniella; L Valvo; P Bertocchi; L Manna; M Bartolomei; S Alimonti; A L Rodomonte |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't Date: 2007-12-26 |
Journal Detail:
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Title: Journal of pharmaceutical and biomedical analysis Volume: 48 ISSN: 0731-7085 ISO Abbreviation: J Pharm Biomed Anal Publication Date: 2008 Sep |
Date Detail:
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Created Date: 2008-09-08 Completed Date: 2008-12-03 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8309336 Medline TA: J Pharm Biomed Anal Country: England |
Other Details:
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Languages: eng Pagination: 303-9 Citation Subset: IM |
Affiliation:
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Dipartimento del Farmaco, Istituto Superiore di Sanità Viale Regina Elena, 299, 00161, Rome, Italy. mariacristina.gaudiano@iss.it |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Anti-Bacterial Agents
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analysis*,
standards Chromatography, Liquid / methods* Fraud |
| Chemical | |
Reg. No./Substance:
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0/Anti-Bacterial Agents |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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