Sustainable and Economical in Vitro Analytical Method Development and Validation of Tedizolid Phosphate in Rabbit Plasma Using RP-HPLC Follows ICH M10 Guidelines

Abstract

A simple, Accurate, precise method was developed for the simultaneous estimation of Tedizolid Phosphate in Rabbit plasma was developed and validated. By using Centrifugation technique, the sample preparation was prepared. Chromatogram run through Std Agilent C18 Column, 4 µm, and 4.6 mm X 250 mm, Mobile phase containing Acetonitrile: Buffer Ortho Phosphoric Acid taken in the ratio 60:40 v/v was pumped through column at a flow rate of 1.0 ml/min OPA.in this method was buffer. For the separation of Tedizolid Phosphate Internal Standard [IS] used is Ciprofloxacin. The Temperature was maintained at 30°C. Optimized wavelength selected was 252 nm.  Retention time of Tedizolid Phosphate and Internal Standard were found to be 3.564 min and 2.982 min. The standard curve was linear (R2 >0.999) over the concentration range of 75 – 3000 ng/ml. All the analytical validation parameters were determined as per ICH guidelines the bioanalytical method developed approach was selective, robust, and reliable, as accuracy, precision, recovery, and other validation parameters were all within the recommendations' limitations. The peaks produced for the drug of interest and the internal standard were well separated from one another without any plasma interferences, and the peaks were symmetrical with an adequate tailing factor. The method has the potential to be very beneficial in therapeutic drug monitoring (TDM), bioequivalence research, pharmacokinetics studies, toxicology, and biomedical investigations.