Determination of Synthetic Precursors as Impurities in Diclofenac Sodium Raw Material

Abstract

Impurities of drug substances may produce some side effects in patient. Diclofenac Na is a member of non-steroidal anti inflammatory drugs (NSAIDs) family, which is routinely used by patients for the treatment of rheumatoid arthritis and various pains. To develop a method for the determination of synthetic precursors which could be remained as impurities in raw drug materials, Na diclofenac powder was chosen in this study. High performance liquid chromatography was used to detect and separate diclofenac from its usual precursors. The chromatographic conditions were as follows: column; C18, mobile phase; methanol/water (55/45), flow rate; 1 ml/min, wavelength of detector; 254nm. The chromatogram obtained showed a reasonable separations of Na diclofenac and its precursors. This method of analysis is applicable in the final product inspection of Na diclofenac raw material.