Validation of a HPLC method for the determination of diclofenac diethylamine and three of its impurities in a gel pharmaceutic form.

Abstract

Monitoring impurities in drug products is a principal requirement of pharmaceutical regulatory authorities all over the world to ensure drug safety. For this reason, there is a great need of analytical quality control of dugs products. In this study, a simple, efficient and direct high performance liquid chromatography (HPLC) method was developed for the determination of three impurities of diclofenac. The HPLC method was developed using the mobile phase which consisted of HPLC grade mixture (Acetonitrile and 0.01M phosphoric acid adjusted to pH = 2.3) in the ratio of (25:75 v/v) respectively. The separation was performed in 15 minutes. The calibrations curve of the three impurities were linear; the correlation coefficient was 0.999 at a concentration of (0.00015 - 0.003 µg/mL). The validation of this method shows that this method meets all validation criteria. This shows the reliability of the use of this method for the routine control of diclofenac impurities. The validation of a robust HPLC method for the determination of diclofenac impurities is of great importance for the pharmaceutical industry to control its products.