Development and validation of a capillary electrophoresis-indirect photometric detection method for the determination of the non-UV-absorbing 1,4-dideoxy-1,4-imino-D-arabinitol in active pharmaceutical ingredients, solutions and tablets using an internal standard.
A high speed, selective, and robust capillary electrophoresis (CE) method with high capacity was developed and validated for determination of assay of 1,4-dideoxy-1,4-imino-D-arabinitol in active pharmaceutical ingredients, solutions, and tablets during the development work at preclinical and Phase I and II clinical studies. 1,4-Dideoxy-1,4-imino-D-arabinitol, tartrate has (almost) no UV absorption. Therefore, the developed CE method for quantification was based on indirect UV detection. A cation CE principle was chosen using an electrolyte at pH 4.0 containing dimethyldiphenylphosphonium hydroxide, which has a strong UV absorbance. The quantification was performed using internal standard technique, by which piperidine was used as internal standard. The method was validated. The validation results showed that the CE method was suitable for the assay (and dissolution) analysis.
Jamali
Babak
B
Department of Analytical Development, CMC Development, R&D, Novo Nordisk A/S, Novo Nordisk Park, DK-2760 Maaloev, Denmark. bjam@novonordisk.com
Nielsen
Hanne Marie
HM
D001089:Arabinose; D002138:Calibration; D004355:Drug Stability; D019075:Electrophoresis, Capillary / Q000379:methods* / Q000592:standards; D050113:Imino Furanoses; D016014:Linear Models; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D010783:Photometry; D011786:Quality Control; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012996:Solutions; D013402:Sugar Alcohols / Q000032:analysis*; D013607:Tablets / Q000737:chemistry; D014466:Ultraviolet Rays
D050113:Imino Furanoses; D004364:Pharmaceutical Preparations; D012996:Solutions; D013402:Sugar Alcohols; D013607:Tablets; C058137:1,4-dideoxy-1,4-iminoarabinitol; D001089:Arabinose