ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF FLUCONAZOLE AND TINIDAZOLE IN BULK AND TABLET DOSAGE FORM BY RP-HPLC Authors: Dandamudi SP , BOGGULA N, SAYEED M, SHIMMULA RR, CHINTHALA SP AND MANDHADI JR*
ABSTRACT
An analytical method consists of a detailed, stepwise list of instructions to be followed in the
qualitative, quantitative or structural analysis of a sample for one or more analytes and using
a specified technique. A facile and rapid isocratic reverse phase high performance liquid
chromatography assay method has been developed for simultaneous estimation of
fluconazole and tinidazole in bulk and tablet. A waters HPLC system with Empower
software was used. Inertsil ODS Column with phosphate buffer of pH 3.0 and methanol in
the ratio of (70:30 v/v) as mobile phase at flow rate of 1 ml/min was employed for the
analysis. The column was maintained at ambient temperature (27 0C). The eluent was
monitored using PDA detector at 210nm. The run time was found to be 8 min. The
developed method was validated as per ICH (International Conference on Harmonisation)
guidelines. The developed method was found to be linear over a workable drug
concentration, accurate, precise and robust. This fast and inexpensive method is suitable for
research laboratories as well as for quality control analysis in pharmaceutical industries.
Keywords: RP-HPLC, isocratic, validation, fluconazole, tinidazole, precision
Publication date: 01/12/2022 https://ijbpas.com/pdf/2022/December/MS_IJBPAS_2022_6685.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2022/11.12.6685