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ISSN 2063-5346
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ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ITRACONAZOLE AND TERBINAFINE IN COMBINE DOSAGE FORMS BY RP HPLC METHOD

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Mahesh Banda, Nandini Manthapuram, Sahithi Reddy Gennepally, Srinivas Ampati
» doi: 10.48047/ecb/2023.12.si7.467

Abstract

This study introduces a novel RP-HPLC technique for simultaneous measurement of Itraconazole and Terbinafine. To get the best results, we ran a series of experiments C18 ODS Agilent make column with 4.6*150mm at a temperature of 5, a pumping flow of 1 ml/min, and a MP ratio of (70:30 v/v) to separate Itraconazole and Terbinafine. The detection wavelength was 254 nm and the medium was methanol: (KH2PO4and KH2PO4) pH 3. Both Itraconazole (101.27%) and Terbinafine (99.99%) passed their purity tests with comparable findings. The analysis method was validated in accordance with ICH standards (ICH, Q2 (R1)). Linearity study conducted on the medications Itraconazole and Terbinafine throughout the concentration ranges of 50 mg to 250 mg and 5 mg to 50 mg, respectively, revealed recoveries of 99.56 and 99.48%, respectively. Intermediate precision had an RSD of 0.1, while repeatability was 0.2. Reliability and repeatability of the research were not compromised in any way.

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