RP-HPLC METHOD & VALIDATION FOR ESTIMATION OF FLURBIPROFEN IN BULK AND ITS FORMULATION

Abstract

                   A simple, precise, accurate, and validated Reverse Phase High-Performance Liquid Chromatographic (RP-HPLC) method was developed for the estimation of Flurbiprofen in bulk drug and pharmaceutical dosage forms. Chromatographic separation was achieved using a C18 column under isocratic conditions. The optimized mobile phase consisted of Acetonitrile and Phosphate Buffer (60:40, v/v), adjusted to pH 4.5, which provided a sharp and reproducible peak for Flurbiprofen. The analysis was carried out at a detection wavelength of 247 nm with a flow rate of 1.0 mL/min. The developed method exhibited excellent chromatographic performance with satisfactory retention time, peak symmetry, and resolution. The method was validated according to International Council for Harmonisation (ICH) guidelines with respect to system suitability, specificity, linearity, accuracy, precision, robustness, limit of detection (LOD), and limit of quantification (LOQ). The calibration curve showed good linearity over the selected concentration range with a correlation coefficient close to unity. Recovery studies demonstrated the accuracy of the method, while intra-day and inter-day precision studies indicated excellent reproducibility with percentage relative standard deviation (%RSD) within acceptable limits. The method was found to be robust against small deliberate changes in chromatographic conditions and showed adequate sensitivity for routine analysis. The validated RP-HPLC method was successfully applied for the quantitative estimation of Flurbiprofen in bulk drug and pharmaceutical formulations. The results confirmed that the proposed method is simple, rapid, accurate, precise, economical, and suitable for routine quality control analysis of Flurbiprofen in pharmaceutical industries and research laboratories.