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 01/2007; 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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    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.
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    ABSTRACT: New, accurate, sensitive and reliable kinetic spectrophotometric method for the assay of atorvastatin calcium (AVS) in pure form and pharmaceutical formulations has been developed. The method involves the oxidative coupling reaction of AVS with 3-methyl-2-benzothiazolinone hydrazone hydrochloride monohydrate (MBTH) in the presence of Ce(IV) in an acidic medium to form colored product with lambdamax at 566 nm. The reaction is followed spectrophotometrically by measuring the increase in absorbance at 566 nm as a function of time. The initial rate and fixed time methods were adopted for constructing the calibration curves. The linearity range was found to be 2.0 - 20.0 g/mL for initial rate and fixed time methods. The limit of detection for initial rate and fixed time methods is 0.093 and 0.064 g/mL, respectively. Molar absorptivity for the method was found to be 3.36 × 104 L/ mol cm. Statistical treatment of the experimental results indicates that the methods are precise and accurate. The proposed method has been applied successfully for the estimation of atorvastatin calcium in commercial dosage forms with no interference from the excipients. The results are compared with the pharmacopoeial method.
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