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Journal of Biomedicine and Biotechnology
Volume 2011 (2011), Article ID 196238, 7 pages
http://dx.doi.org/10.1155/2011/196238
Research Article

Direct Determination of ECD in ECD Kit: A Solid Sample Quantitation Method for Active Pharmaceutical Ingredient in Drug Product

1Chemical Analysis Division, Institute of Nuclear Energy Research, Taoyuan 32546, Taiwan
2Isotope Application Division, Institute of Nuclear Energy Research, Taoyuan 32546, Taiwan
3Institute of Nuclear Energy Research (INER), Taoyuan 32546, Taiwan

Received 31 December 2010; Revised 25 February 2011; Accepted 11 March 2011

Academic Editor: David J. Yang

Copyright © 2011 Ming-Yu Chao et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Technetium-99m ethyl cysteinate dimer (Tc-99m-ECD) is an essential imaging agent used in evaluating the regional cerebral blood flow in patients with cerebrovascular diseases. Determination of active pharmaceutical ingredient, that is, L-Cysteine, N, N′-1,2-ethanediylbis-, diethyl ester, dihydrochloride (ECD) in ECD Kit is a relevant requirement for the pharmaceutical quality control in processes of mass fabrication. We here presented a direct solid sample determination method of ECD in ECD Kit without sample dissolution to avoid the rapid degradation of ECD. An elemental analyzer equipped with a nondispersive infrared detector and a calibration curve of coal standard was used for the quantitation of sulfur in ECD Kit. No significant matrix effect was found. The peak area of coal standard against the amount of sulfur was linear over the range of 0.03–0.10 mg, with a correlation coefficient ( 𝑟 ) of 0.9993. Method validation parameters were achieved to demonstrate the potential of this method.