A stability-indicating high performance liquid chromatographic assay for the determination of orlistat in capsules

Mohammadi, A. and Haririan, I. and Rezanour, I. and Ghiasi, L. and Walker, R.B. (2006) A stability-indicating high performance liquid chromatographic assay for the determination of orlistat in capsules. Journal of Chromatography A, 1116 (1/2). pp. 153-157. ISSN 0021-9673

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Official URL: http://dx.doi.org/10.1016/j.chroma.2006.03.038

Abstract

A stability-indicating HPLC method was developed and validated for the quantitative determination of orlistat in capsule dosage forms. An isocratic separation was achieved using a Perfectsil® target ODS-3, 250 mm × 4.6 mm i.d., 5 μm particle size column with a flow rate of 0.7 ml/min and using a UV detector to monitor the eluate at 210 nm. The mobile phase consisted of methanol:acetonitrile:trifluoroacetic acid (82.5:17.5:0.01, v/v/v). The drug was subjected oxidation, hydrolysis, photolysis and heat to apply stress conditions. Complete separation was achieved for the parent compound and all degradation products in an overall analytical run time of approximately 15 min with the parent compound orlistat eluting at approximately 9 min. The method was linear over the concentration range of 0.02-0.75 mg/ml (r = 0.9998) with a limit of detection and quantitation 0.006 and 0.02 mg/ml, respectively. The method has the requisite accuracy, selectivity, sensitivity and precision to assay orlistat in capsules. Degradation products resulting from the stress studies did not interfere with the detection of orlistat and the assay is thus stability-indicating.

Item Type:Article
Uncontrolled Keywords:HPLC-UV; Orlistat; Stability-indicating
Subjects:Y Unknown > Subjects to be assigned
Divisions:Faculty > Faculty of Pharmacy
ID Code:796
Deposited By: Mrs Eileen Shepherd
Deposited On:24 Aug 2007
Last Modified:06 Jan 2012 16:19
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