RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF FLURBIPROFEN
Lolla Sai Kalyan*, Deepthi P
KLR Pharmacy College, Paloncha, Bhadradri Kothagudem, Telangana- 507511, India
Specifically, this study aims to develop and validate a Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method to measure the quantity of Flurbiprofen in pharmaceutical dosage forms by analyzing their RP-HPLC data. With a C18 column and a mobile phase consisting of an optimized ratio of buffer and organic solvent, chromatographic separation was achieved, and detection was carried out using a UV lamp. According to the ICH Q2(R1) guidelines, the method was validated for critical parameters such as specificity, linearity, precision (intraday and interday), accuracy, robustness, system suitability, limit of detection (LOD), and limit of quantification (LOQ). A correlation coefficient was used to confirm linearity over a specific concentration range. In precision studies, low relative standard deviations (RSDs) were demonstrated, and recovery tests confirmed the method's accuracy. Despite minor variations in chromatographic conditions, robustness testing showed the method's reliability. Validated RP-HPLC method for routine quantification of Flurbiprofen in pharmaceutical quality control is simple, precise, and suitable.
15 , 1 , 2025
9 - 17