UV Spectrophotometric/HPLC Method Development, Validation and F2 Factor for Quantitative Estimation of Diclofenac Sodium with Market Product

For the quantification of Diclofenac Sodium in Pharmaceuticals dosage form by using High Performance Liquid Chromatography (RP-HPLC). Chromatographic separation was obtained by using chromatographic conditions on a system for obtaining the results according to USP specifications. The retention time (RT) was 7.6 min per analysis with mobile phase acetonitrile 40% and solution A 60%. The symmetry of column was 15cm x 4.6 mm with packing 5-μm L1 with flow rate 1.5mL/min and wavelength detected on 280nm by using Photodiode array detector. The validation has established the linearity, accuracy, precision, limit of detection (LOD), limit of quantitation (LOQ), and robustness of the test method. The calibration curve we obtained was linear with lowest concentration range 0.01mg/ml to highest concentration range 0.4mg/ml with same RT. The accuracy and precision were also within acceptable range ± 2.0 %. The behaviour of DS was different at room temperature and at freeze. All results were acceptable and this confirmed that the method is suitable for its intended use in routine quality control and assay of drugs.