Micro-determination of ketoconazole in plasma or serum by high-performance liquid chromatography

Bioequivalence evaluation of two brands of ketoconazole tablets (Onofin‐K® and Nizoral®) in a healthy female Mexican population

“…T max was observed 2 h after drug administration and the last samples were sufficient for calculating at least 80% of AUC 0Àa . All calculated pharmacokinetic parameters are summarized in Table 3 and agree with previous reported values [9,10,16] except with those reported by Yuen and Peh [11], who observed the same values with fluorescent detection employing a dose of 200 mg, which was half the dose used in this and other work.…”

Optimization and validation of a high-performance liquid chromatographic method with UV detection for the determination of ketoconazole in canine plasma

“…A similar effect of food on absorption rates has been also observed in humans after administration of a single 200-mg tablet formulation of ketoconazole [22]. The slow absorption rates of ketoconazole in the fed state in both dogs and humans confirm the usefulness of the proposed method, to measure very low ketoconazole concentration in plasma, versus previously reported HPLC methods with much higher LOQ values [8][9][10][11][12].…”

“…In addition, tedious and time consuming preparation procedures, such as sample evaporation and reconstitution aiming for lower limits of detection, were eliminated. However, the limit of detection of the developed method, is comparable with the lowest existing in the literature for HPLC methods [6] with UV [6][7][8][9][10][11][12], MS [16] and fluorimetric [13,14] detection.…”

“…Among them microbiological assays [4,5] lack specificity because they are based on measurement of antifungal activity, which may not only be due to ketoconazole but to other bioactive plasma components or metabolites as well. HPLC methods with UV [6][7][8][9][10][11][12], fluorescence [13,14], electrochemical [15] and MS-MS [16] detection have been reported in plasma samples. Chen et al [16] have summarized the limitations of all the above HPLC methods.…”

“…Chen et al [16] have summarized the limitations of all the above HPLC methods. More specifically, main drawbacks of the existing HPLC methods with UV detections are either high detection limits (>50 ng/ml) [8][9][10][11][12], or complicated and time consuming sample preparation procedures including liquid-liquid extraction, evaporation and reconstitution in order to lower LODs [6][7][8]12] or long total time elution time (>20 min) with the internal standard eluted after ketoconazole [7][8][9][10] or lack of internal standard [6,11,12]. The aim of the present work was to develop and validate a simple, fast and reliable isocratic RP-HPLC method with UV detection for the determination of ketoconazole in plasma samples.…”