Ion-pairing liquid chromatographic method determination of ketoconazole and stress degradation in pharmaceutical formulations with fluorescence detection
Braz. J. Pharm. Sci. (Online)
;
56: e00087, 2020. tab, graf
Article
Dans Anglais
|
LILACS-Express
| LILACS
| ID: biblio-1089213
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 4555 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.
Texte intégral:
Disponible
Indice:
LILAS (Amériques)
Type d'étude:
Etude diagnostique
langue:
Anglais
Texte intégral:
Braz. J. Pharm. Sci. (Online)
Thème du journal:
Farmacologia
/
Teraputica
/
Toxicologia
Année:
2020
Type:
Article
Pays d'affiliation:
Thaïlande
Institution/Pays d'affiliation:
Pibulsongkram Rajabhat University/TH
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