Analytical Method Development and Validation For Dissolution of Flucloxacillin From Its Tablet Dosage Form

Abstract

High Performance Liquid Chromatography(HPLC) method was developed and validated for Dissolution of Flucloxacillin Sodium Tablet. Different Analytical Parameters such as Linearity, Precision, Accuracy, Specificity, Solution Stability, Filter Study. were determined according to International Conference of Harmonization ICH Q2(R1) guidelines. The RP HPLC method was developed Isocratic Technique on a reversed phase Inertsil ODS 3V C18 Column (150mm*4.6mm) 5 μ. The mobile phase was selected as Phosphate buffer pH5.0 using KH2PO4 and ACN (60:40). The retention time for Flucloxacillin was 4.0±1 minute. The flow rate was kept 1 mL/min and Injection volume was kept 20 μL. The column temperature was kept Ambient 25˚C and Sample temperature was kept 10˚C.The wavelength was kept 225nm based on UV Spectroscopy. The linearity of calibration curve for flucloxacillin in the desired concentration range was good (r2 =0.999) by HPLC. The method showed good reproducibility and recovery with percent relative standard deviation less than 2%. The Solution was found to be stable having percent Difference between Initial Hour and Final Hour of less than 2%. The specificity showed no interference of placebo and Diluent with main peak of Drug. The Proposed method is highly sensitive, precise and accurate and hence successfully applied for in vitro dissolution of a marketed formulation.