Abstract
Ion-pairing liquid chromatographic method was validated for determination of ketoconazole in shampoo and cream samples as per ICH guidelines. The chromatographic conditions were carried out in the isocratic mode using a mixture of methanol and 8 mM sodium dodecyl sulfate (pH 5.5) in a ratio of 45:55 v/v %, as mobile phase. The flow rate was set at 1.0 mL min-1. Chromolith RP-18e (100×4.6 mm) was used as the analytical column with a fluorescence detection at an excitation wavelength of 260 nm and an emission wavelength of 375 nm. The average percentage recovery of shampoo A, shampoo B, shampoo C, cream A and cream B were 99.88, 97.06, 99.58, 96.77 and 97.26, respectively. The limit of detection was 0.12 mg L-1. The drug decomposition under acid degradation, base degradation and oxidative degradation were found to be in the range of 91.63-94.70% indicating that the drug is resistant towards acidic conditions. The drug decomposition under thermal condition and photolysis condition were found to be in the range of 69.05-87.15% and 47.31-66.83% respectively, indicating that the drug decomposition is more sensitive under photolysis conditions. This method is suitable for the quality control of ketoconazole in commercial shampoo and creams.
Highlights
Ketoconazole (cis-1-acetyl-4-[4-[[2-(2,4dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3dioxolan-4-yl]methoxy]phenyl]piperazine is an imidazole antifungal agent
The results showed excellent correlations within the tested concentrations ranges
We found some drawbacks in those methods, which are listed below; almost all of those methods have used organic solvents more than 60%, which is not cost effective for routine analysis in pharmaceutical industries, mobile phase containing organic phase may be detrimental to HPLC analytical column as at that concentration, buffer salts may precipitate and interference caused by different excipients used in newly developed formulation with ketoconazole peak may occur
Summary
Ketoconazole (cis-1-acetyl-4-[4-[[2-(2,4dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3dioxolan-4-yl]methoxy]phenyl]piperazine is an imidazole antifungal agent. Ketoconazole is available in many dosage forms; cream, shampoo, solution, gel and foam. The side effects of ketoconazole are itching, nausea, vomiting, abdominal pain, headache, dizziness, fatigue, impotence and blood count abnormalities. Ketoconazole 1% shampoo is used to treat dandruff and ketoconazole 2% shampoo is used to treat sun fungus. These shampoos may cause abnormal hair texture, scalp pustules, dry skin and itching. There may be oiliness and dryness of the
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