METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF LEVOFLOXACIN AND AZITHROMYCIN BY RP-HPLC IN TABLET DOSAGE FORM

The aim of the study was method development and validation for simultaneous estimation of levofloxacin and azithromycin by rp-hplc in tablet dosage form. To evaluate system suitability parameters such as retention time, tailing factor and USP theoretical plate count, the mobile phase was allowed to flow through the column at a flow rate of 1.0 ml/min to equilibrate the column at ambient temperature. Analysis was carried out at 265 nm. Chromatographic separation was achieved by injecting a volume of 20 μL of standard into Agilent ZorbaxC18, 250x4.6, 5µ, the mobile phase of composition Phosphate Buffer: Methanol (40:60 % v/v) was allowed to flow through the column at a flow rate of 1.0 ml per minute. The proposed method will be validated as per ICH guidelines. The objective of the proposed work is to develop a new, simple, sensitive, accurate and economical analytical method and validation for the Simultaneous estimation of Levofloxacin, Azithromycin in pharmaceutical dosage form by using HPLC. To validate the developed method in accordance with ICH guidelines for the intended analytical application i.e., to apply the proposed method for analysis of the drug in its dosage form.

Keywords: Levofloxacin, Azithromycin, Method Development, Validation, Accuracy, Precision.