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

Journal of the Brazilian Chemical Society

A. Venkateshwarlu²  A. V. Rama Rao²  Mukkanti Khagga¹  S. V. Subba Reddy² 

[1] ,Avra Laboratories Private Limited Analytical Development Laboratory Hyderabad,India

关键词: 10-hydroxycamptothecin;    (R)-enantiomer;    validation;    anti-cancer activity;    quantification;    HPLC;   

DOI  :  10.5935/0103-5053.20130271

来源: SciELO

【 摘 要 】

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.

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