Determination of Synthetic Precursors as Impurities in Diclofenac Sodium Raw Material

authors:

avatar Mohammad Hassan Houshdar Tehrani 1 , * , avatar Farnoush Farnia 1 , avatar Maryam Emami 1

Department of Pharmaceutical Chemistry, School of Pharmacy, Shaheed Beheshti University of Medical Sciences and Health Services, Tehran, Iran

how to cite: Houshdar Tehrani M H, Farnia F, Emami M. Determination of Synthetic Precursors as Impurities in Diclofenac Sodium Raw Material. Iran J Pharm Res. 2002;1(1):e127586. https://doi.org/10.22037/ijpr.2010.10.

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.