A Validated Chiral LC Method for the Determination of Enantiomeric Purity of Pemetrexed Disodium on an Amylose-Based Chiral Stationary Phase |
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Authors: | K Ramulu B M Rao P Madhavan M Lalitha Devi M K Srinivasu K B Chandrasekhar |
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Institution: | (1) Analytical Research, Custom Pharmaceutical Services, Dr. Reddy’s Laboratories, Hyderabad, 500049, India;(2) Department of Chemistry, J.N.T.U. College of Engineering, Anantapur, 515002, India |
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Abstract: | A simple and new isocratic normal phase chiral HPLC method has been developed for the determination of enantiomeric purity
of pemetrexed disodium (l-enantiomer) in bulk drugs with a short run time of about 20 min. Chromatographic separation of l and d-enantiomers of pemetrexed disodium was achieved on an amylose based chiral stationary phase using a mobile phase consists
of hexane, ethanol and trifluoro acetic acid. The resolution between the enantiomers was found to be more than 2.0. The system
precision and method precision were found to be within 5% RSD for the distomer (d-enantiomer) at its specification level (i.e. not more than 1.0% w/w). The limit of detection and limit of quantification of distomer were 1.6 and 5 μg mL−1, respectively for 10 μL injection volume. The percentage recovery of distomer was ranged from 90.6 to 105.7 in bulk drug
samples. The test solution was found to be stable in the diluent for 48 h. The method was found to be specific for the enantiomers
of pemetrexed disodium and can be conveniently used for the quantification of undesired d-enantiomer present in the bulk drug samples of pemetrexed disodium. |
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Keywords: | Column liquid chromatography Enantiomeric purity Validation and quantification Pemetrexed disodium |
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