title: Validation of stationary phases in (111)In-pentetreotide planar chromatography.
abstract: BACKGROUND
  Since Pall-German stopped manufacturing ITLC-SG, it has become necessary to validate alternative stationary phases.
  
  
  OBJECTIVE
  To validate different stationary phases versus ITLC-SG Pall-Gelman in the determination of the radiochemical purity (RCP) of (111)In-pentetreotide ((111)In-Octreoscan) by planar chromatography.
  
  
  METHODS
  We conducted a case-control study, which included 66 (111)In-pentetreotide preparations. We determined the RCP by planar chromatography, using a freshly prepared solution of 0,1M sodium citrate (pH 5) and the following stationary phases: ITLC-SG (Pall-Gelman) (reference method), iTLC-SG (Varian), HPTLC silica gel 60 (Merck), Whatman 1, Whatman 3MM and Whatman 17. For each of the methods, we calculated: PRQ, relative front values (RF) of the radiopharmaceutical and free (111)In, chromatographic development time, resolution between peaks. We compared the results obtained with the reference method. The statistical analysis was performed using the SPSS program. The p value was calculated for the study of statistical significance.
  
  
  RESULTS
  The highest resolution is obtained with HPTLC silica gel 60 (Merck). However, the chromatographic development time is too long (mean=33.62minutes). Greater resolution is obtained with iTLC-SG (Varian) than with the reference method, with lower chromatographic development time (mean=3.61minutes). Very low resolutions are obtained with Whatman paper, essentially with Whatman 1 and 3MM. Therefore, we do not recommend their use.
  
  
  CONCLUSIONS
  Although iTLC-SG (Varian) and HPTLC silica gel 60 (Merck) are suitable alternatives to ITLC-SG (Pall-Gelman) in determining the RCP of (111)In-pentetreotide, iTLC-SG (Varian) is the method of choice due to its lower chromatographic development time.
authors.affiliation: Unidad de Gestión Clínica de Medicina Nuclear, Instituto Maimónides de Investigación Biomédica de Córdoba, Hospital Universitario Reina Sofía, Universidad de Córdoba, Córdoba, España. estefania.moreno.sspa@juntadeandalucia.es
authors.forename: E
authors.initials: E
authors.lastname: Moreno-Ortega
authors.forename: L M
authors.initials: LM
authors.lastname: Mena-Bares
authors.forename: F R
authors.initials: FR
authors.lastname: Maza-Muret
authors.forename: F J
authors.initials: FJ
authors.lastname: Hidalgo-Ramos
authors.forename: J A
authors.initials: JA
authors.lastname: Vallejo-Casas
mesh_terms: D002854:Chromatography, Paper / Q000295:instrumentation / Q000379:methods*; D002855:Chromatography, Thin Layer / Q000295:instrumentation / Q000379:methods*; D004340:Drug Contamination; D007205:Indium Radioisotopes / Q000032:analysis*; D010209:Paper; D019275:Radiopharmaceuticals / Q000032:analysis*; D012016:Reference Values; D058428:Silica Gel; D013004:Somatostatin / Q000031:analogs & derivatives* / Q000032:analysis
chemical_list: D007205:Indium Radioisotopes; D019275:Radiopharmaceuticals; D013004:Somatostatin; D058428:Silica Gel; C081788:pentetreotide
keywords: Cromatografía de capa fina instantánea-gel de sílice; Instant thin layer chromatography-silica gel; Octreoscan; Pentetreotide; Pentetreótida; Pureza radioquímica; Radiochemical purity