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A RP-HPLC Method for the Determination of Ketoconazole in Pharmaceutical Dosage Forms

[ Vol. 13 , Issue. 6 ]

Author(s):

Olga Popovska, Zoran Kavrakovski and Vesna Rafajlovska   Pages 505 - 511 ( 7 )

Abstract:


Background: Ketoconazole is an antifungal drug, available in different pharmaceutical dosage forms. The current published methods for the ketoconazole determination confirmed the primacy of the HPLC method, but high toxic solvents were used, also.

Introduction: A new simple, precise, accurate, and cost-effective RP-HPLC method for the determination of ketoconazole in tablets, topical cream, and shampoo has been developed and validated.

Method: The chromatographic separation was conducted on a LiChrospher®100 C-18 column (150 mm length x 4.6 mm i.d., 5 µm particle size) using a mixture of methanol and water (90:10 v/v) adjusted to pH 8.90 with a phosphate buffer. The HPLC analysis was carried out at 25 °C column temperature with 1.0 mL/min isocratic flow rate of the mobile phase. The robustness of the method was evaluated changing the flow rate of the mobile phase (0.9 mL/min and 1.0 mL/min) and the column temperature (23 °C and 25 °C).

Result: The mean recovery data for the ketoconazole pharmaceutical dosage forms were in the range of 92.67–105.23%.

Conclusion: The developed and validated method was successfully used for the quantitative analysis of ketoconazole pharmaceutical dosage forms; tablets, topical cream, and shampoo.

Keywords:

Cream, DAD, ketoconazole, methanol, shampoo, tablets.

Affiliation:

Institute of Organic Technology, Faculty of Technology and Metallurgy, Ss. Cyril and Methodius University, Rudjer Boskovic 16, 1000 Skopje, Institute of Applied Chemistry and Pharmaceutical Analyses, Faculty of Pharmacy, Ss. Cyril and Methodius University, Majka Tereza 47, Skopje, Institute of Organic Technology, Faculty of Technology and Metallurgy, Ss. Cyril and Methodius University, Rudjer Boskovic 16, 1000, Skopje

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