A SPECIFIC STABILITY INDICATING HPLC METHOD TO DETERMINE DICLOFENAC SODIUM IN RAW-MATERIALS AND PHARMACEUTICAL SOLID DOSAGE FORMS

A high performance liquid chromatography method is described for the determination of diclofenac sodium, its related compounds and degradation products in commercial sources of raw materials and solid dosage forms. This method is specific, accurate and stability indicating. The method employs a reverse-phase octylsilane (C18) column with a mobile phase composed of acetonitrile/methanol/pic B-6 (25:25:50) and detection at 229 nm. The method resolves six principal related compounds with quantitation in the range 0.3 - 1.5%. Assay recoveries by spiking commercial formulations with diclofenac sodium were 99.64 +/- 1.30%. Drug content in several commercial formulations are reported. Accelerated stability tests were conducted on raw materials and drug products and 1-(2,6-dichlorophenyl)-2-indolin-2-one was identified for the first time as a degradation product in solid dosage forms which are stressed under humidity and heat.