A STABILITY INDICATING RP-HPLC METHOD FOR DETERMINATION OF ITRACONAZOLE IN BULK DRUG AND IN CAPSULE DOSAGE FORM
DETERMINATION OF ITRACONAZOLE IN BULK DRUG AND IN CAPSULE DOSAGE FORM
Keywords:Itraconazole, Forced Degradation, HPLC, Stress testing, Stability Indicating
Stability Indicating RP HPLC method was developed for estimation of Itraconazole in bulk drug and in capsule dosage form. An isocratic separation was achieved using Phenomenex symmetry C8 (250 ×4.6 mm) 5μm [Part number - 00G-4249-E0] column with a flow rate of 1.0 ml/min and detection wavelength at 254 nm. The mobile phase consisted of 20 mM potassium dihydrogen orthophosphate buffer (pH=5.5): Acetonitrile: Methanol (20:40:40 % v/v). The method was rectilinear from 10-60 μg/ml and displayed adequate precision (RSD < 2.0%) & accuracy (99.31-101.16%). The proposed method is found to be specific with respect to degradation product formed after Acidic hydrolysis, Oxidation, Thermal and Photolytic degradation. The Itracoazole was found to be stable under alkaline stress condition. Acidic, thermal, photolytic stress conditions showed moderate degradation whereas the oxidative stress condition showed severe degradation. The proposed chromatographic method can be used for estimation of drug during stress testing & formal stability studies.
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Copyright (c) 2021 Shalin Parikh, Jayant Dave, Jayendrakumar Patel, Bhavesh Bhavsar
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