Key result
Validated reversed phase HPLC method simultaneously quantifies clopidogrel, acetylsalicylic acid, and atorvastatin.
Why the study?
A simple, rapid, and precise method for simultaneous estimation of clopidogrel bisulfate, acetylsalicylic acid, and atorvastatin calcium in tablets was needed for quality control analysis.
A validated HPLC method allows for the simultaneous quantification of clopidogrel, aspirin, and atorvastatin in tablet formulations.
May aid quality control of co-prescribed CV drugs; extends analytical options for polypharmacy research.
The concept of multidrug therapy with clopidogrel, acetylsalicylic acid and atorvastatin provides major advances for patients with acute coronary syndromes (ACS) treated invasively and conservatively to reduce the risk of ischemic events and improve survival. Dual antiplatelet therapy (DAPT) with acetylsalicylic acid and clopidogrel is currently the treatment of choice in acute coronary syndromes and prevention of thrombosis after coronary stent implementation. Present paper presents a simple, rapid and precise reversed phase high performance liquid chromatographic method for simultaneous estimation of clopidogrel hydrogen sulfate, acetylsalicylic acid and atorvastatin calcium from tablet dosage form. The cromatographic analysis was carried out using a ThermoFinnigan Chromatograph with UV detection and separation on an HDS Hypersil C18 column. The elution was isocratic with mobile phase consisting in mixture of 0.01M KH₂PO₄ buffer: acetonitrile: methanol. Chemicals were represented by clopidogrel bisulfat, atorvastatin calcium and acetylsalicylic acid standards with high purity. The quality control samples used in the accuracy and precision evaluation were spiked at low, medium and high concentration levels. Preliminary tests were performed to select optimum conditions for simultaneous separation of all three analytes such as mobile phase composition, proportion and pH. A satisfactory separation of all three drugs was achieved with a mobile phase of 0.01 M KH₂PO₄ buffer (pH adjusted to 2.6 with phosphoric acid):acetonitrile:methanol 20:40:40 v/v/v at flow rate of 0.8 ml/min. The proposed method was validated for linearity, precision and accuracy. The validated method can be successfully applied for simultaneous quantification of clopidogrel, acetylsalycilic acid and atorvastatin either in combination or in single dosage form in quality control analysis. The analytical conditions can also be performed for human plasma analysis.
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Spiridon et al. (2015) studied this question. HPLC method for simultaneous estimation of clopidogrel, acetylsalicylic acid and atorvastatin was evaluated on Method validation for linearity, precision and accuracy. A reversed phase high performance liquid chromatographic method was successfully developed and validated for the simultaneous quantification of clopidogrel, acetylsalicylic acid, and atorvastatin.
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