Key result
A stability-indicating RP-HPLC method was successfully developed and validated for the simultaneous determination of aspirin and clopidogrel in combined dosage forms.
A new stability-indicating RP-HPLC method allows for the simultaneous determination of aspirin and clopidogrel in dosage forms under various stress conditions.
May support quality-control testing of aspirin-clopidogrel combinations; leaves open routine adoption pending independent verification.
Stability-indicating High Performance Liquid Chromatographic (HPLC) method was developed for simultaneous Aspirin and Clopidogrel, A Phenomenex Gemini C-18, 5 m 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.
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Gousuddin et al. (2016) studied this question. RP-HPLC method was evaluated on Method validation (linearity, precision, accuracy). A stability-indicating RP-HPLC method was successfully developed and validated for the simultaneous determination of aspirin and clopidogrel in combined dosage forms.
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