Qualitative and quantitative analysis of clopidogrel bisulphate polymorphs.
This study deals with characterization and quantification of form I and form II of clopidogrel bisulphate (CLP), a selective and irreversible inhibitor of ADP-induced platelet aggregation. Thermal (DSC, TGA, HSM), crystallographic (XRD) and spectroscopic (FTIR) methods were used for characterization. After characterization of active pharmaceutical ingredient (API), these techniques were further used for identification of the polymorphic form present in three marketed formulations (tablets). FTIR method was successfully developed and validated for the quantification of form I in polymorph mixtures.
Koradia
Vishal
V
Department of Pharmaceutical Technology (Formulations), National Institute of Pharmaceutical Education and Research (NIPER), Sector-67, S.A.S. Nagar, Punjab-160 062, India.
Chawla
Garima
G
Bansal
Arvind K
AK
D002626:Chemistry, Pharmaceutical / Q000379:methods; D000077144:Clopidogrel; D003460:Crystallization / Q000379:methods; D005069:Evaluation Studies as Topic; D007194:India; D015394:Molecular Structure; D011110:Polymorphism, Genetic / Q000235:genetics; D011208:Powders; D017550:Spectroscopy, Fourier Transform Infrared / Q000379:methods; D013607:Tablets; D013988:Ticlopidine / Q000031:analogs & derivatives* / Q000032:analysis* / Q000737:chemistry* / Q000627:therapeutic use; D014961:X-Ray Diffraction / Q000379:methods
D011208:Powders; D013607:Tablets; D000077144:Clopidogrel; D013988:Ticlopidine