title: Validation of a Stability-Indicating Method for Methylseleno-L-Cysteine (L-SeMC).
abstract: Methylseleno-L-cysteine (L-SeMC) is a naturally occurring amino acid analogue used as a general dietary supplement and is being explored as a chemopreventive agent. As a known dietary supplement, L-SeMC is not regulated as a pharmaceutical and there is a paucity of analytical methods available. To address the lack of methodology, a stability-indicating method was developed and validated to evaluate L-SeMC as both the bulk drug and formulated drug product (400 µg Se/capsule). The analytical approach presented is a simple, nonderivatization method that utilizes HPLC with ultraviolet detection at 220 nm. A C18 column with a volatile ion-pair agent and methanol mobile phase was used for the separation. The method accuracy was 99-100% from 0.05 to 0.15 mg/mL L-SeMC for the bulk drug, and 98-99% from 0.075 to 0.15 mg/mL L-SeMC for the drug product. Method precision was <1% for the bulk drug and was 3% for the drug product. The LOQ was 0.1 µg/mL L-SeMC or 0.002 µg L-SeMC on column.
authors.affiliation: MRIGlobal, 425 Volker Boulevard, Kansas City, MO 64110, USA.
authors.forename: Kristin
authors.initials: K
authors.lastname: Canady
authors.affiliation: MRIGlobal, 425 Volker Boulevard, Kansas City, MO 64110, USA.
authors.forename: Johnathan
authors.initials: J
authors.lastname: Cobb
authors.affiliation: MRIGlobal, 425 Volker Boulevard, Kansas City, MO 64110, USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Deardorff
authors.affiliation: MRIGlobal, 425 Volker Boulevard, Kansas City, MO 64110, USA jlarson@mriglobal.org.
authors.forename: Jami
authors.initials: J
authors.lastname: Larson
authors.affiliation: MRIGlobal, 425 Volker Boulevard, Kansas City, MO 64110, USA.
authors.forename: Jonathan M
authors.initials: JM
authors.lastname: White
authors.affiliation: The National Cancer Institute, 9609 Medical Center Drive, Room 5E536, Rockville, MD 20850, USA.
authors.forename: Dan
authors.initials: D
authors.lastname: Boring
mesh_terms: D000818:Animals; D002853:Chromatography, Liquid / Q000379:methods*; D057230:Limit of Detection; D051381:Rats; D012015:Reference Standards; D017279:Selenocysteine / Q000031:analogs & derivatives* / Q000032:analysis / Q000493:pharmacokinetics
chemical_list: D017279:Selenocysteine; C002979:selenomethylselenocysteine