Venkateshwarlu, A; Rama Rao, AV; Mukkanti, K; Subba Reddy, SV
Objective: The objective of the method was to develop a new and simple, rapid, isocratic, normal phase chiral HPLC method for the enantiomeric separation of (S)-7-ethyl-10-hydroxycamptothecin(SN-38){(S)-4,11-Diethyl-4,9-dihydroxy-1H-pyrano[3',4;6,7] indolizino[1,2-b]quinoline-3,14(4H,12H)-dione, an anti-cancer drug substance. Methods: In this method, a Chiralpak IC (Daicel Chemical Industries, Ltd., Tokyo, Japan) (immobilized polysaccharide chiral stationary phase) column with a mobile phase consisting of n-hexane:ethanol (50:50 v/v) at a flow rate of 1.0 mL/min was used. The elution was monitored at 225 nm and column oven temperature at 40 °C. Results: The limit of detection and limit of quantification of R-enantiomer were found to be 0.032 μg/mL and 0.07 μg/mL respectively for 10 μL injection volume. The sample solution and mobile phase were found to be stable for at least 48 hr. The linearity was showed a regression coefficient of 0.9993. The resolution between both the enantiomers was greater than 3.5 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. Conclusion: The developed method was simple, fast, accurate and precise and hence could be applied for routine quality control analysis for quantitative determination of (R)-enantiomer in bulk drug substance and product.
