నైరూప్య

A validated chiral HPLC method for the determination of frovatriptan and its enantiomer in drug substance

RamalingamMurugan, S.Sriman Narayanan

A simple direct Chiral HPLC method was developed for the separation of the enantiomers of Frovatriptan Succinate[R-(+)-6-Carboxamido-3-Nmethylamino- 1,2,3,4-tetrahydrocarbazole hemisuccinate], an antimigraine drug. The enantioseparation was achieved on a Protein based Cellobiohydrolase column (Chiral-CBH) using an isocratic mobile phase consisting of 10mM dihydrogen orthophosphate buffer and methanol in the ratio of 92:8. Flow rate was kept at 0.6 ml/min. The resolution between the enantiomers was 4.4. The developed method was capable of detecting the S-enantiomer up to 6 ng/ml. The method was validated in terms of Selectivity, Linearity, Precision,Accuracy, Robustness, Limit of Detection (LOD) and Limit ofQuantitation (LOQ).