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Development and validation of a RP-HPLC method for determination of atorvastatin calcium and aspirin in a capsule dosage form

Indian Journal of Pharmaceutical Sciences (Impact Factor: 0.3). 02/2007; 69(4). DOI: 10.4103/0250-474X.36942
Source: DOAJ

ABSTRACT A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the simultaneous determination of atorvastatin calcium and aspirin in capsule dosage forms. A phenomenex Gemini C-18, 5 mm column having 250 x 4.6 mm i.d. in isocratic mode, with mobile phase containing 0.02 M potassiumdihydrogen phosphate: methanol (20:80) adjusted to pH 4 using ortho phosphoric acid was used. The flow rate was 1.0 ml/ min and effluents were monitored at 240 nm. The retention times of atorvastatin calcium and aspirin were 5.4 min and 3.4 min, respectively. The linearity for atorvastatin calcium and aspirin were in the range of 0.5-4 mg/ml and 5-25 mg/ml, respectively. The recoveries of atorvastatin calcium and aspirin were found to be in the range of 98.02-100.68% and 98.38-101.42%, respectively. The proposed method was validated and successfully applied to the estimation of atorvastatin calcium and aspirin in combined capsule dosage forms.

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    • "Therefore, atorvastatin is most frequently prescribed in combined formulations of different drugs. A thorough literature survey reveals that determination of atorvastatin alone or in combination with other drugs viz., fenofibrate [2] [3] [4], ezetimibe [5] [6], losartan [7], telmisartan [8], metformin and glimeperide [9], glimeperide [10], aspirin [11], clopidogrel and aspirin [12], losartan, aspirin and atenolol [13] was reported. The afore mentioned analytical methods have been developed in order to allow quantitative determination of a maximum of three combinations. "
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