Development and validation of a RP-HPLC method for determination of atorvastatin calcium and aspirin in a capsule dosage form
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.
- SourceAvailable from: Ragampeta Srinivas
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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   , ezetimibe  , losartan , telmisartan , metformin and glimeperide , glimeperide , aspirin , clopidogrel and aspirin , losartan, aspirin and atenolol  was reported. The afore mentioned analytical methods have been developed in order to allow quantitative determination of a maximum of three combinations. "
ABSTRACT: A new rapid and sensitive high performance liquid chromatography (HPLC) method has been developed for the simultaneous determination of atorvastatin—an antihyperlipidemic drug along with most commonly prescribed drugs (antihyperlipidemic, antihypertensive, antidiabetic, antithrombotic) in bulk and marketed combined formulations. The chromatographic separation was carried out by gradient elution mode with acetonitrile as organic modifier and 0.1% triethylamine acetate (TEAA) buffer pH 5 at a flow rate of 1 mL/min and a diode array detector at wavelength 230 nm was employed for detection of the analytes. Calibration curves were linear in the range of 5–150 μg/mL for all the drugs with correlation coefficients of determination (r2 values)≥0.999. Limits of detection (LODs) and Limits of quantification (LOQs) ranged from 0.1 to 0.27 μg/mL and 0.3 to 0.89 μg/mL respectively. Intra-day and inter-day precision was studied at three concentration levels (20, 60 and 100 μg/mL). The intra-day and inter-day RSD for all compounds was less than 2.0%. The accuracy for all compounds was found to be between 98% and 102%. Thus, the performance of the method described allows its use in quantification of atorvastatin along with 9 most commonly prescribed drugs available in market as atorvastatin combined dosage forms.Journal of Pharmaceutical Analysis 08/2012; 2(4):285–292. DOI:10.1016/j.jpha.2012.02.006
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ABSTRACT: A reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of atorvastatin calcium and fenofibrate in tablet formulation. The separation was achieved by Luna C18 column and methanol:acetate buffer pH 3.7 (82:18 v/v) as mobile phase, at a flow rate of 1.5 ml/min. Detection was carried out at 248 nm. Retention time of atorvastatin calcium and fenofibrate was found to be 3.02+0.1 and 9.05+0.2 min, respectively. The method has been validated for linearity, accuracy and precision. Linearity for atorvastatin calcium and Fenofibrate were in the range of 1-5 mug/ml and 16-80 mug/ml, respectively. The mean recoveries obtained for Atorvastatin calcium and fenofibrate were 101.76% and 100.06%, respectively. Developed method was found to be accurate, precise, selective and rapid for simultaneous estimation of atorvastatin calcium and fenofibrate in tablets.Indian Journal of Pharmaceutical Sciences 04/2008; 70(2):263-5. DOI:10.4103/0250-474X.41473 · 0.30 Impact Factor
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ABSTRACT: Atorvastatin Calcium and Ramipril are used in combination for treatment of hypertension. The present work deals with simple spectrophotometric method development for simultaneous estimation of Atorvastatin Calcium (ATR) and Ramipril (RAM) in two component capsule formulation. The method employed first order derivative spectroscopy 1 . For determination of sampling wavelength 10 µg/ml of each of ATR and RAM were scanned in 200-350 nm range and sampling wavelengths were 294 nm for ATR were RAM showed zero crossing point and 229 nm for RAM were ATR showed zero crossing point in first order derivative spectroscopy. For this method linearity observed in 5-40 µg/ml for ATR and 2-20 µg/ml for RAM. The recovery studies confirmed accuracy of proposed method and low values of standard deviation confirmed precision of method. The method is validated as per ICH guidelines. INTRODUCTION: