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Development of Validated RP-HPLC Method for the Estimation of Itraconazole in Pure and Pharmaceutical Dosage Form


Affiliations
1 Department of Pharmaceutical Analysis, SIMS College of Pharmacy, Mangaldas Nagar, Guntur-522 002 (A.P.), India
     

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A simple, fast and precise RP-HPLC method was developed for the quantification of Itraconazole in pure and pharmaceutical dosage form. The quantification was carried out using Dionex C18 4.6 X 250mm, 5μm enhanced polar selectivity column and mobile phase comprised of methanol and pH 7.5 potassium dihydrogen phosphate in the ratio of 40:60 and degassed under ultrasonication. The flow rate was 1.5ml/min and the effluent was monitored at 306nm. The retention time of Itraconazole was found to be 5.2 min. The method was validated in terms of linearity, precision, accuracy, specificity, robustness, limit of detection and limit of quantitation in accordance with ICH guidelines. Linearity of Itraconazole was in the range of 200-600 μg/mL. The percentage recoveries of Itraconazole were 99.33% to 99.66% from the capsule formulation. The proposed method is suitable for determination of Itraconazole in pharmaceutical dosage form.

Keywords

Chromatography, Itraconazole, Method Validation.
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  • Development of Validated RP-HPLC Method for the Estimation of Itraconazole in Pure and Pharmaceutical Dosage Form

Abstract Views: 254  |  PDF Views: 0

Authors

B. Thangabalan
Department of Pharmaceutical Analysis, SIMS College of Pharmacy, Mangaldas Nagar, Guntur-522 002 (A.P.), India
M. Salomi
Department of Pharmaceutical Analysis, SIMS College of Pharmacy, Mangaldas Nagar, Guntur-522 002 (A.P.), India
N. Sunitha
Department of Pharmaceutical Analysis, SIMS College of Pharmacy, Mangaldas Nagar, Guntur-522 002 (A.P.), India
S. Manohar Babu
Department of Pharmaceutical Analysis, SIMS College of Pharmacy, Mangaldas Nagar, Guntur-522 002 (A.P.), India

Abstract


A simple, fast and precise RP-HPLC method was developed for the quantification of Itraconazole in pure and pharmaceutical dosage form. The quantification was carried out using Dionex C18 4.6 X 250mm, 5μm enhanced polar selectivity column and mobile phase comprised of methanol and pH 7.5 potassium dihydrogen phosphate in the ratio of 40:60 and degassed under ultrasonication. The flow rate was 1.5ml/min and the effluent was monitored at 306nm. The retention time of Itraconazole was found to be 5.2 min. The method was validated in terms of linearity, precision, accuracy, specificity, robustness, limit of detection and limit of quantitation in accordance with ICH guidelines. Linearity of Itraconazole was in the range of 200-600 μg/mL. The percentage recoveries of Itraconazole were 99.33% to 99.66% from the capsule formulation. The proposed method is suitable for determination of Itraconazole in pharmaceutical dosage form.

Keywords


Chromatography, Itraconazole, Method Validation.