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Enantioseparation of Palonosetron Hydrochloride and Its Related Enantiomeric Impurities by Computer Simulation and Validation

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American Journal of Analytical Chemistry 2011年第4期2卷 437-446页

作者： M.Vishnu Murthy C.Krishnaiah Kodithyala Jyothirmayi katkam srinivas K.Mukkanti Ramesh Kumar Gautam Samanta Analytical Research and Development Integrated Product Development OperationsDr.Reddy’s Laboratories Ltd.BachupallyQutubullapurAndhra PradeshIndia Department of Chemistry Jawaharlal Nehru Technological UniversityHyderabadIndia

A rapid, simple and single stereo selective high-performance liquid chromatographic (HPLC) method was developed and validated for enantiomers of palonosetron hydrochloride (PALO) and its process related chiral impurities. A computer simulating software was used for the development of chiral method. The developed method was able to separate not only the enantiomers of palonosetron hydrochloride but also its process related chiral impurities within 12 min. The chromatographic separation was carried out by normal phase chromatography using a 3 μm column of cellulose based chiral stationary phase (Chiralcel-OD 250mm × 4.6mm) with a mobile phase comprised of n-hexane: ethanol: methanol: heptafluoro butyric acid: diethyl amine (70:15:15:0.05:0.1, v/v) at a flow rate of 1.0 mL/min. The effects of additive concentration as well as nature of polar organic modifier, flow rate, and temperature on enantioselectivity were investigated. The limit of detection (LOD) and limit of quantification (LOQ) of the palonosetron isomers and its related chiral impurities were found to be in the range 0.06-0.10 μg/mL and 0.14 - 0.24 μg/mL respectively. The method showed excellent linearity (R2 > 0.998) over a range of 0.14 to 1.125 μg/mL. The percentage recovery of the isomers in bulk drug samples ranged from 87.0 to 116.0.

关键词： High Performance Liquid Chromatography Palonosetron Hydrochloride Chiral Impurities Drylab^(█) Software Method Development Method Validation

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