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.
10-hydroxycamptothecin; (R)-enantiomer; validation; anti-cancer activity; quantification; HPLC
