| Title | Determination of ketoconazole in capsules by high-performance liquid chromatography and microbiological assay. | | Author(s) | Lima PM, Prado ND, Silva ML, Diniz RD, Queiroz KM, César Ida C, Pianetti GA, Santos DA | | Institution | Universidade Vale do Rio Doce, Faculdade de Ciências da Saúde, Laboratório de Microbiologia, Rua Israel Pinheiro, 2000, Bairro Universitário, 35020-220, Governador Valadares, Minas Gerais, Brazil. | | Source | J AOAC Int 2009 Jul-Aug; 92(4):1076-81. | | Abstract | The development and validation of an HPLC-UV method and a microbiological assay were performed for the analysis of ketoconazole in capsule formulations. The bioassay was developed using a specific agar diffusion technique with the strain of Candida albicans ATCC 18804 as the test organism. The effect of the mobile phase pH in the range of 2.5-7.5 on the retention and tailing factors of the ketoconazole peak was analyzed in the chromatography method and a pH value of 4.5 was considered to be adequate. A prospective validation of both methods showed adequate linearity (r2 > 0.99 for the two methods), precision, (RSD = 2.42% for intraday and 2.69% for interday precision for bioassay; RSD = 0.74% for intraday and 0.66% for interday precision for HPLC-UV), and accuracy (mean recoveries were 103 +/- 1.0% for bioassay and 99 +/- 1.0% for HPLC-UV). Student's t-test revealed no significant difference between the results obtained by the two methods (P < 0.05). The contents found for three capsule samples showed a strong correlation, as attested by Pearson's coefficient value (r = 0.9998), which also evidenced the concordance between the studied methodologies. | | Language | eng | | Pub Type(s) | Journal Article
| | PubMed ID | 19714975 |
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