Analytical Method Validation of Stability  Indicating Hplc Method For Determination of  Assay of Clopidogrel Bisulphate Tablets Uspby  HPCL Method

Ajay Kumar Gupta; P. K. Patel

Volume : III, Issue : II, February - 2014

Analytical Method Validation of Stability Indicating Hplc Method For Determination of Assay of Clopidogrel Bisulphate Tablets Uspby HPCL Method

Ajay Kumar Gupta, P. K. Patel

Abstract :

Clopidogrel is a thienopyridine class antiplatelet agent used to inhibit blood clots in coronary artery disease, peripheral vascular disease and cereovascular disease.The drugs works by irreversibly inhibiting a receptor called P2Y12, an adenosine diphasphate(ADP) chemoreceptor on platelet cell memanes. Adverse effect includes hemorrhage, severe neutropenia, and thrombic thrombocytopenic purpura (TTP).which is important in activation of platelets and eventual cross-linking by the protein fiin 1. The method is developed and validate by using ULTRON ES-OVM column (150 x 4.6mm,5 �m) containing Buffer :Acetonitrile mobile phase in (75 : 25) . Theflow rateissetat1.0ml/minuteandtheinjectionvolume is 10μl. Theruntimeof clopidogrel was 15.0 min. Thelinearityofmethodis 0.50-150.60μg/ml,thecorrelation coefficientisfoundtobe0.9999. EluentsweremonitoredbyUVdetectorat220nm. The method was validated as per ICH guideline for various parameters like precision, linearity, accuracy, ruggedness and robustness.