DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR ITRACONAZOLE CAPSULE FORMULATION
Vaishnavi C. Tajne* and A. V. Chandewar
ABSTRACT
Itraconazole ia an orally administerd triazole antifungal agent. A Selective and simple HPLC method was developed for Itraconazole capsule which was operated on EPIC-C12(250mm×4.6mm,5μm). The mobile phase used Methyl alcohol (60%), Acetonitrile (20%), water (20%) and Trifluroacetic acid(0.1%) solution at the flow rate of 1.0 ml/min. Itraconazole was detected at 4.9 min retention time, at 262nm wavelength. The correlation coefficient for Itraconazole was 0.9979 in 30-90μm/ml respectively, System precision studies were performed by
injecting 6 repeated injections of 100% concentration of standard solution. precision for Itraconazole was found to be 0.65% RSD, for accuracy sample at 80%,100%,120% and accuracy was 100.37.The LOD-3:1 and LOQ-10:1.The method Validated with respect to linearity, precision, limit of Detection and limit of Qantification. The results of validation studies show that the HPLC Method is sensitive, accurate and precise.
Keywords: Itraconazole, HPLC, Acetonitrile, TFA, MeOH.
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