A novel high performance liquid chromatography method development and validation of fluconazole by ezchrom software

Abstract

The current research explains the development of a new method and its subsequent validation by a novel HPLC method in fluconazole tablets. Inertsil Octadecyl silica C18 column having dimensions of length 150 mm, diameter 4.6 mm, particle size 5 μm was exploited for the method development, and the mobile phase embodies buffer pH 4 and acetonitrile in the combo of 40:60. Wavelength exploited for the segregation was 289 nm. The volume of injection was preserved at 20 µl. The new developed method has been established to demonstrate linearity in the range of 10 to 30 µg /ml correspondingly. Average recovery established to be 101.571, 100.315, and 99.021, the standard deviation was established to be 0.93834, 0.986418, and 0.989741, and % R.S.D was established to be 0.92382, 0.98331, and 0.999526. The percentage recovery was established to be within prescribed restrictions. The limit of detection was established to be 0.0080. The limit of quantitation was established to be 0.0051. In assay studies, an average assay was found to be 95.966, and standard deviation and % RSD of the assay was found to be 0.6021 and 0.6274, respectively. The method was found to be specific as there was no intrusion from impurities and excipients. Extensive diversity of mobile phase combos was utilized for the research and flow rate preserved at 1.3 ml/min all through the process. After carefull and systemic investigation of various research articles and review articles, it is observed that H.P.L.C method development and validation of fluconazole has been done in various pharmaceutical dosage forms, but till now a smaller amount of work is executed on dosage forms of solid nature, and hence there is huge prospective for research to be done in this area for new methodology to be developed in pharmaceutical dosage form of solid nature by means of dissimilar mobile phase combos and different strategy adopted by use of chromatography software which avoids the problems and demerits associated with present methods