DEVELOPMENT AND VALIDATION OF A HPLC METHODS FOR DETERMINATION OF DEXIBUPROFEN IN PHARMACEUTICAL PREPARATIONS
Keywords:
Dexibuprofen, High-performance liquid chromatography (HPLC), Pharmaceutical preparations, Method development, Method validation, Quantification, C18 column, Methanol-phosphate buffer, Specificity, Linearity.Abstract
This review presents the development and validation of a high-performance liquid chromatography (HPLC) method for the accurate determination of Dexibuprofen in pharmaceutical preparations. Dexibuprofen, the active enantiomer of ibuprofen, is known for its enhanced therapeutic efficacy and reduced adverse effects. The developed method involved the optimization of chromatographic conditions using a C18 column with a mobile phase composed of methanol and phosphate buffer at pH 3.0, pumped at a flow rate of 1.0 mL/min. Dexibuprofen was detected at a wavelength of 220 nm. The method was validated according to ICH guidelines for parameters including specificity, linearity, precision, accuracy, robustness, and system suitability. The method exhibited excellent linearity (R2 > 0.999) over the concentration range of 5-100 µg/mL with high precision and accuracy. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.5 µg/mL and 1.0 µg/mL, respectively. The proposed method was successfully applied for the determination of Dexibuprofen in commercial pharmaceutical formulations, demonstrating its suitability for routine quality control analysis. Overall, the developed HPLC method offers a reliable and sensitive approach for the quantification of Dexibuprofen in pharmaceutical preparations, ensuring quality and consistency in drug formulations.
