Meliha Ekinci
Ege University, Turkey
Title: Radioanalytical chromatography techniques for newly developed radiopharmaceutical: 99mTcibandronate sodium
Biography
Biography: Meliha Ekinci
Abstract
Statement of the Problem: Bisphosphonates (BPs) are chemically stable pyrophosphate analogues, and used to treat pathological conditions associated with bone mass loss. Radiolabeled BPs, which used as bone-seeking radiopharmaceuticals for imaging or therapy hold an important place in nuclear medicine, radiopharmaceuticals are radioactive drugs containing a pharmaceutical compound and a suitable radionuclide. While biologically active molecule or drug acts as a carrier and determines localization, the radionuclide permits external detection. FDA approved radiopharmaceuticals as drugs and it is mandatory to satisfy the guidelines for quality control tests which include the radiochemical, radionuclidic and chemical purity as well as checks for pharmaceutical concerns. In the past 10 years, separation and quality control methods such as radioactive thin layer chromatography (RTLC), high performance liquid chromatography (HPLC) and electrophoresis have widely used in radiopharmaceutical studies. In radiopharmaceutical research laboratories, it is important that the labeled compound is obtained in high yields. Radiolabeled agents may contain impurities like unlabeled radionuclide used for radiolabeling, with degradation products formed during oxidation or reduction of radionuclide and secondary complexes which should be formed during radiolabeling reaction. Thus, the estimation of impurities in the radiolabeled compounds is significant.99mTc-ibandronate sodium (99mTc-IBD), was developed and quality control studies were achieved by using RTLC and paper electrophoresis methods. For this purpose, different stationary and mobile phases were used and ideal TLC system conditions were developed. Furthermore, paper electrophoresis studies were performed for each formulation. 99mTc-IBD complex was prepared by using different reducing agent concentrations. Some parameters like effect of antioxidant agent and pH on labeling yield were also investigated. For quality control methods, Whatman 1 MM and 3 MM papers, silica gel (SG) coated fiber sheets and instant thin layer chromatography SG (ITLC-SG) plates were used as stationary phase and acetone, physiologic solution, methylethylketon, acetonitrile/water/ trifluoroacetic acid, butanol/ethanol/water solutions were used as mobile phases.