Method Development and Validation of Fluconazole and Itraconazole by Using RP-HPLC (Research Article)

Author(s): Vani Bhavani.D, Kadiri Sunil Kumar*, Sathish Kumar M, N. Jyothi and Arunabha Mallik

Abstract: The development and validation of the Fluconazole and Itraconazole is performed by a rapid, sensitive, and reliable RP-HPLC technique using a Waters HPLC System with PDA detection was designed and validated. Chromatography was carried out on an Inertsil -ODS C18 (250 x 4.6 mm, 5) column with a flow rate of 1.0 ml/min. Temperature was held at an ambient (room temperature). The optimized selected wavelength was 257 nm using filtered and mixed Degassed Methanol: Acetonitrile (70:30) as a mobile phase. Fluconazole retention period is 3.049 minutes while Itraconazole retention times are 4.316 minutes. The values of LOD, LOQ obtained for the fluconazole and itraconazole by using the relative equations were 5.06 and 1.69 respectively. This process was validated according to the ICH (International conference for harmonization) guidelines accuracy, precision, linearity, and robustness.

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