SRTXRF Analysis in Different Pharmaceutical Forms of Diclofenac Sodium.

The quality of medicine depends upon the production processes and on chemical, physical, and physical-chemical properties of the drug (i.e., the active ingredient) and pharmaceutical excipients used in the formulation. The presence of impurities can inhibit the process of dissolution of medicine and the formulation components, among them metals, can be associated with the clinical effectiveness and bioavailability. The purpose of this work was to verify the presence of trace metals in different batches and pharmaceutical forms of diclofenac sodium using synchrotron radiation total reflection X-ray fluorescence analysis (SRTXRF). Different batches of medicines from six laboratories were analyzed. The results indicated variation in individual masses of the commercial medicine and in the nature and concentrations of the trace elements detected. Elements measured include Al, Si, P, S, Cl, K, Ca, Ti, Cr, Mn, Fe, Ni, Cu, Zn, Br, Rb, and Sr. The SRTXRF shows high sensitivity for the elements considered; it is, therefore, ideal for elemental characterization in solid pharmaceutical products. [ABSTRACT FROM AUTHOR]