Abstract
Objective: To develop a novel, accurate, precise and linear reverse phase high-performance liquid chromatography (RP-HPLC) and Stability Indicating Assay Method (SIAMs) for simultaneous, qualitative and quantitative estimation of aspirin, rosuvastatin and clopidogrel in bulk and pharmaceutical dosage form as per International Conference on Harmonization (ICH) guidelines.Method: In the present work, good chromatographic separation was achieved by isocratic method using a BISCOF HPLC C18 column (250 mm ×4.6, 5 µm) and a mobile phase consisting of water at pH 2.51 with 0.1 % (v/v) orthophosphoric acid (OPA): acetonitrile in the ratio 50:50, at a flow rate of 1 ml/min. The effluents obtained were monitored at 237 nm with the UV-visible detector.Results: The retention time of aspirin, rosuvastatin, and clopidogrel was found to be 4.3 min, 7.6 min and 16.6 min respectively. For linearity seven-point calibration curves were obtained in a concentration range from 1-7 µg/ml for aspirin, rosuvastatin and clopidogrel with correlation coefficient 0.999, 0.9989, 0.9988 respectively. The high recovery values (99%-101%) indicate a satisfactory accuracy. The low percent relative standard deviation (% RSD) values in the precision study reveal that the method is precise. In the present study stability indicating an RP-HPLC method for the combination was tested by degrading the drugs together under various stress condition like acid, base and neutral hydrolysis, oxidation, thermal and photolytic stress which is recommended by ICH.Conclusion: The developed RP-HPLC method is simple, economic, specific, accurate and precise for the simultaneous estimation of aspirin, rosuvastatin, and clopidogrel in the combined capsule dosage form. The developed stability indicating analytical method can be used to check the stability of the compounds and was found suitable to determine % degradation of drugs in pharmaceutical dosage form.
Highlights
Platelet aggregation and thrombus formation play a critical role in the initiation and development of key complications of acute coronary syndromes (ACSs)
HMG-CoA Reductase catalyzes the conversion of HMG-CoA to mevalonic acid, the rate-limiting step in cholesterol biosynthesis and it is used to reduce plasma cholesterol levels and prevent cardiovascular disease (CVD), antiplatelet therapy and antithrombotic therapy have been demonstrated to modify clinical outcome favorably, and recent trials of revascularization in ACSs have demonstrated a reduction in the frequency of major cardiac events [1,2,3]
Rosumac gold capsule manufactured by Macleod Pharmaceuticals, Mumbai, containing the labeled amount of 75 mg aspirin, 10 mg rosuvastatin, and 75 mg Clopidogrel was purchased from local markets
Summary
Platelet aggregation and thrombus formation play a critical role in the initiation and development of key complications of acute coronary syndromes (ACSs). All effective antithrombotic agents increase the risk of bleeding. Bleeding that results from vascular accessories associated with surgery, including coronary artery bypass grafting (CABG) [4,5,6]. Aspirin is a non-steroidal anti-inflammatory drug that exhibits anti-inflammatory, analgesic and antipyretic activities. Clopidogrel bisulfate, chemically it is [S-(a)(2chlorophenyl)-6,7-dihydrothieno (3,2-C) pyridine-5 (4H) acetic acid methyl ester sulfate].
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