Abstract

POLYMORPHIC ESTIMATION OF CLOPIDOGREL HYDROGEN SULFATE FORM-II IN CLOPIDOGREL HYDROGEN SULFATE FORM-I BY X-RAY DIFFRACTOMETER

Dr. Amit Gosar, Mr. Shivaji Jadhav,*Mr. Mithun Gharat, Mr. Dnyandev Kadu and Mr. Mahesh Patil

ABSTRACT

Clopidogrel hydrogen sulfate Form-I possibly may convert into Clopidogrel hydrogen sulfate Form-II and determination of Clopidogrel hydrogen sulfate form-II content with accurate quantitation is difficult and Clopidogrel hydrogen sulfate Form-II determination method is not reported in literature. Hence, novel specific and accurate method has been developed for the Polymorph estimation of Clopidogrel hydrogen sulfate Form-II by X-ray crystallography. The method has been developed and validated as per International conference on Harmonization guidelines (Q2R1) and found out specific Linear, Precise and accurate in validation. The described method is accurate and validated and successfully applied for the Polymorph estimation of Clopidogrel hydrogen sulfate Form-II in Clopidogrel hydrogen sulfate Form-I.

Keywords: Polymorphism, XRD, Clopidogrel Hydrogen Sufate, Analytical Method Development, Analytical Method Validation.