Determination of Ketoconazole in Capsules by High-Performance Liquid Chromatography and Microbiological Assay

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 2.57.5 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.

Stability Indicating RP-HPLC Method For Determination Of Ketoconazole In Bulk Drug And In Tablet Dosage Form

“…[6] RP-HPLC method is published for determination of KZ in different dosage form and also with combination of other drugs. [7], [8], [9], [10],[11], [12] All these studies have further emphasized the need to perform rapid and sensitive qualitycontrol analysis of pharmaceutical formulations containing KZ. The developed Stability Indicating HPLC method has been validated according to ICH Q2 (B) guideline.…”