Stability Indicating Rp-hplc Method for Simultaneous Determination of Aspirin and Clopidogrel in Dosage Form

Stability-indicating High Performance Liquid Chromatographic (HPLC) method was developed for simultaneous Aspirin and Clopidogrel, A Phenomenex Gemini C-18, 5 μm column having 250mm x 4.6 mm i.d. in isocratic mode, with mobile phase containing buffer solution 0.3% orthophosphoric acid : acetonitrile (65: 35, v/v). The flow rate was 1 ml/min and effluents were monitored at 266 nm. For linearity seven points calibration curve were obtained in a concentration range from 0.030 –0.120 mg/ml for aspirin and 0.015 – 0.060 mg/ml for clopidogrel with correlation coefficient 0.9999. In the present study stability indicating HPLC method for the combination was tested by degrading the drugs together under various stress conditions like acid hydrolysis, base hydrolysis, oxidation, thermal and photolytic stress which is recommended by ICH guideline.