A stability-indicating high performance liquid chromatographic (HPLC) assay for the simultaneous determination of atorvastatin and amlodipine in commercial tablets

Mohammadi, A. and Rezanour, N. and Ansari Dogaheh, M. and Ghorbani Bidkorbeh, F. and Hashem, M. and Walker, R.B. (2007) A stability-indicating high performance liquid chromatographic (HPLC) assay for the simultaneous determination of atorvastatin and amlodipine in commercial tablets. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 846 (1/2). pp. 215-221. ISSN 1570-0232

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Official URL: http://dx.doi.org/10.1016/j.jchromb.2006.09.007

Abstract

A simple, rapid, precise and accurate isocratic reversed-phase stability-indicating HPLC method was developed and validated for the simultaneous determination of atorvastatin (AT) and amlodipine (AM) in commercial tablets. The method has shown adequate separation for AM, AT from their associated main impurities and their degradation products. Separation was achieved on a Perfectsil® Target ODS-3, 5 μm, 250 mm × 4.6 mm i.d. column using a mobile phase consisting of acetonitrile–0.025 M NaH2PO4 buffer (pH 4.5) (55:45, v/v) at a flow rate of 1 ml/min and UV detection at 237 nm. The drugs were subjected to oxidation, hydrolysis, photolysis and heat to apply stress conditions. The linearity of the proposed method was investigated in the range of 2–30 μg/ml (r = 0.9994) for AT and 1–20 μg/ml (r = 0.9993) for AM. The limits of detection were 0.65 μg/ml and 0.35 μg/ml for AT and AM, respectively. The limits of quantitation were 2 μg/ml and 1 μg/ml for AT and AM, respectively. Degradation products produced as a result of stress studies did not interfere with the detection of AT and AM and the assay can thus be considered stability-indicating.

Item Type:Article
Uncontrolled Keywords:Amlodipine; Atorvastatin; Simultaneous HPLC-UV; Stability-indicating
Subjects:Y Unknown > Subjects to be assigned
Divisions:Faculty > Faculty of Pharmacy
ID Code:726
Deposited By: Mrs Eileen Shepherd
Deposited On:03 Jul 2007
Last Modified:06 Jan 2012 16:18
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