Qualitative and quantitative analysis of clopidogrel bisulphate polymorphs

Area of Science:

• Pharmaceutical Sciences
• Solid-State Chemistry

Background:

• Clopidogrel bisulphate (CLP) is a crucial antiplatelet medication.
• Understanding its polymorphic forms (form I and form II) is vital for drug efficacy and stability.
• Polymorphism can significantly impact the bioavailability and therapeutic performance of CLP formulations.

Purpose of the Study:

• To comprehensively characterize clopidogrel bisulphate (CLP) forms I and II.
• To identify and quantify these polymorphic forms in marketed tablet formulations.
• To develop and validate a spectroscopic method for quantitative analysis of CLP polymorphs.

Main Methods:

• Thermal analysis: Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA), Hot Stage Microscopy (HSM).
• Crystallographic analysis: X-ray Diffraction (XRD).
• Spectroscopic analysis: Fourier Transform Infrared (FTIR) spectroscopy, method development and validation.

Main Results:

• Characterization of CLP forms I and II using a combination of thermal, crystallographic, and spectroscopic techniques.
• Identification of the specific polymorphic form present in three different marketed tablet formulations.
• Successful development and validation of an FTIR method for accurate quantification of form I in mixtures with other polymorphs.

Conclusions:

• The study provides a thorough characterization of clopidogrel bisulphate polymorphs.
• The developed FTIR method is effective for quantifying polymorphic mixtures in pharmaceutical products.
• This research contributes to quality control and formulation development of clopidogrel bisulphate medications.