The development and validation of a chiral high performance liquid chromatography method for the identification and quantification of (R)-enantiomer in 10-hydroxycamptothecin

• Autor(a) principal: Venkateshwarlu,A.
• Data de Publicação: 2014
• Outros Autores: Rama Rao,A. V., Khagga,Mukkanti, Reddy,S. V. Subba
• Tipo de documento: Artigo
• Idioma: eng
• Título da fonte: Journal of the Brazilian Chemical Society (Online)
• Texto Completo: http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0103-50532014000100009
• topic: 10-hydroxycamptothecin; (R)-enantiomer; validation; anti-cancer activity; quantification; HPLC

A new and simple, rapid, isocratic, normal phase chiral high performance liquid chromatography (HPLC) method was developed and validated for the enantiomeric separation of (S)-10-hydroxycamptothecin (10-HCTN), ((4S)-4-ethyl-4,9-dihydroxy-1H-pyrano[3',4':6,7]indolizino[1,2-b] quinoline-3,14(4H,12H)-dione), an anti-cancer drug substance. The enantiomers of 10-HCTN were resolved on a Chiralpak IC (immobilized polysaccharide chiral stationary phase) column using a mobile phase consisting of n-hexane:ethanol (50:50 v/v) at a flow rate of 1.0 mL min-1. The resolution between both enantiomers was greater than 3 in the optimized method. The developed method was extensively validated and proved to be robust, enantioselective, accurate, precise, and suitable for quantitative determination of (R)-enantiomer in bulk drug substance and product.