Enantiomeric separation and validation of D-isomer in Pemetrexed disodium-An anti-cancer agent using Chiral HPLC

Pemetrexed disodium is an anti-cancer agent. It is an anti-folate drug used for the treatment of malignant pleural mesothelioma and non-small cell lung cancer. In the present study the authors have proposed a chiral HPLC method for the separation and determination of Pemetrexed disodium and its D-isomer using Chiralpak AD-H (250 x 4.6 mm, 5 μm) column within a run time of 30 mins. A mixture of n-Hexane: Ethanol: Isopropyl alcohol: TFA (250: 650: 100: 1) was the final optimized mobile phase composition after many trials for the separation of D-isomer of Pemetrexed disodium (at 35°C) using Waters Alliance 2695 series HPLC system with 2998 photodiode array detector (UV detection at 240 nm). The method is very much useful for the pharmacokinetic studies as well as the metabolite study in vitro and in vivo for the determination of therapeutic activities of optical isomers.