Abstract

STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF ITRACONAZOLE AND TERBINAFINE IN BULK AND TABLET DOSAGE FORMS

Kesharaju Shivaranjani*, Priyanka Bikkasani, Titus Darsi, Damerakonda Kumaraswamy

Abstract

Background: Itraconazole is an Antifungal medication used to treat number of fungal infections. On set of action within an hour and Last upto twenty one hours. Terbinafine is an Antifungal medication used to treat pityriasis versicolor, fungal nail infections and ringworm. On Set of action within an hour and Last up to 36 hours. Objective: To develop and validate simple, fast, economical and eco-friendly RPHPLC method for the estimation of Itraconazole and Terbinafine in bulk and tablet dosage form according to ICH guidelines. Method: This method achieved by Shimadzu LC-20A instrument with isocratic elution with the mobile phase of methanol and water in the ratio of (9.5:0.5v/v) on Zodiac C18 (250mm x 4.6mm, 5μm) with a flow rate of 1mL/min. at a wave length of 257nm with UV detector. Tablets were allowed to undergo different stress conditions like acid, base, oxidation, thermal degradation studies. Results: Retention time of Itraconazole and Terbinafine was found to be 4.288 and 2.551 respectively. The linearity of proposed method investigated in the range of 10-50μg/mL for both Itraconazole and Terbinafine. The Limit of Detection of Itraconzole and Terbinafine 1.25μg/mL and 8.00μg/mL respectively. The Limit of Quantification of Itraconazole and Terbinafine are 3.79μg/mL and 24.00μg/mL respectively. Conclusion: From the above results, it can be concluded that the developed RP-HPLC method represents a good technique for determination of Itraconazole and Terbinafine contents in bulk and tablet formulation with good sensitivity, precision, and reproducibility.

Keywords: Itraconazole, Terbinafine, RP-HPLC, Forced degradation studies.