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NEW METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS DETERMINATION OF ASPIRIN, ATORVASTATIN AND CLOPIDOGREL IN CAPSULE DOSAGE FORM BY HPLC

Tayyaba Mahtab, SK. Ershad Ahmed, Sayeeda Tabasum, N. Pal*, A. Srinivasa Rao

Abstract: A simple, accurate, rapid and precise isocratic reverse phase high performance liquid chromatographic method has been developed and validated for simultaneous determination of aspirin, atorvastatin and clopidogrel in capsule dosage form. The chromatographic separation was carried out on an Inertsil ODS analytical column (250×4.6mm,5µm) with a mixture of solvents phosphate buffer (pH 3.15 adjusted with o-phosphoric acid), acetonitrile and methanol (40:40:20 v/v/v) as mobile phase, at a flow rate of 1.0 ml/minute maintaining the temperature at 30ºc. UV detection was performed at 240 nm. The retention times were 2.4, 3.5 and 4.5 for atorvastatin, aspirin and clopidogrel respectively. The method was validated according to ICH guidelines and the acceptance criteria of results for accuracy, precision, linearity, robustness, limit of detection, limit of quantification and ruggedness were met in all cases. The % RSD values for atorvastatin, aspirin and clopidogrel were found to be 0.101%, 0.547% and 0.515% respectively. The linearity of the calibration curve for each analyte in the desired concentration range was good (r2>0.999). The high recovery and value of low relative standard deviation confirm the suitability of the method for routine evaluation of aspirin, atorvastatin and clopidogrel in pharmaceutical dosage forms. Keywords: Aspirin, atorvastatin, clopidogrel, simultaneous, HPLC.

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