NEW RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ANTIFUNGAL DRUG ITRACONAZOLE IN ITRACONAZOLE LOADED INVASOMES GEL

Abstract

A new simple, accurate, rapid, selective and robust high pressure liquid chromatography (HPLC) method was developed and validated for estimation of itraconazole (ITZ) in bulk and prepared in house invasomes gel formulation. Acetonitrile and Methanol was used as a mobile phase for chromatographic separation in the ratio of 20mM KH2PO4: Acetonitrile (pH adjusted to 4.0 with OPA) at flow rate of 1.0 ml/min and estimation on Thermo C18 (250 × 4.6 mm) in the ratio of 50:50 v/v at flow rate of 1.0 ml/min. The detection was carried out with UV detector set at 262nm. The retention time for itraconazole was found to be 2.258±0.095 minutes. The linearity range for itraconazole was found to be 5-25 μg/ml with coefficient of linear regression 0.998. The method was validated in accordance with the requirements of International Conference on Harmonization (ICHQ2 A 8 B) guidelines for specificity, linearity, accuracy, precision, LOD 8 LOQ.