Analytical Method Development and Validation of Stability Indicating RP-HPLC Method For Assay of Flucloxacillin In Its Tablet Dosage Form

Abstract

Flucloxacillin is a semi-synthetic isoxazolpenicillin class of antimicrobial drug. It can be used to treat bacterial infections caused by microorganisms. A simple and accurate stability indicating RP-HPLC method was developed to determine flucloxacillin sodium by using Inertsil ODS C18 (150mm×4.6mm, 5μ) column and pH 5 Phosphate Buffer: Acetonitrile (70:30 v/v) as a mobile phase at flow rate of 1mL/min, column temperature at 25°C and it was detector by PDA at 225nm. The Rt found to be 9.99 min. This method was validated as per ICH guidelines for various validation parameters. Degradation studies was performed under various stress conditions namely acid, base, thermal, and oxidative for the drug sample. This method was linear at 10-150μg/mL range of concentration and the value of correlation coefficient found to be 0.9999. This method was also specific as there is no interference of impurity/degradant peak on our main peak. The mean recovery value was found to be 97.56%. The method is also robust and %assay was found to be in the limit mentioned in the ICH guidelines.