VALIDATED SPECIFIC HPLC METHOD FOR THE DETERMINATION OF CLOPIDOGREL IN THE PRESENCE OF DEGRADATION PRODUCTS FORMED UNDER ICH STRESS CONDITIONS
The objective of the current investigation was to study the degradation behaviour of clopidogrel hydrochloride under different ICH recommended stress conditions by HPLC and to establish a validated stability indicating HPLC method. The drug was subjected to various stress conditions like hydrolysis, oxidation, photolysis and thermal decomposition. Resolution of the drug from degradation products was achieved on an Inertsil ODS column using buffer-acetonitrile (diammonium hydrogen ortho phosphate and tetrabutyl ammonium hydrogen sulphate) in the ratio of 40:60 as mobile phase. The flow rate was 1.5 ml/min and the detection was carried out at 210 nm using PDA detector. The method was validated with respect to linearity, precision, accuracy, specificity and robustness. The experimental true bias of all samples is lesser than  2%.