Article

A New Spectrophotometric Method Applied to the Simple Determination of Irbesartan in Tablets

Reaserch Journal of Aleppo University 01/2006; 49:49-60.

ABSTRACT A simple and accurate method is presented for determination of irbesartan in pure form and commercial dosage forms. The method is based on the reaction of the above cited drug with bromophenol blue (BPB), bromocresol purple (BCP), bromothymol blue (BTB) and naphthol blue black (NBB) dyes in solutions containing Britton buffer to form ion-pair complexes extractable with chloroform and subsequently measured spectrophotometrically at 420nm for BPB, BCP, BTB and 625nm for NBB. All the reaction conditions for the proposed method have been studied. The reactions were extremely rapid at room temperature and the absorbance values remains unchanged up to 24hrs. Beer's law was obeyed in the ranges 1.8-45, 1.5-43, 2-60 and 10-244 g/mL for BPB, BCP, BTB and NBB, respectively. Interferences of the other ingredients and excipients were not observed. The proposed method is simple, fast and sensitive, and the first reported extractive method for the determination of irbesartan.

2 Bookmarks
 · 
105 Views
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: A selective, accurate and precise high-performance liquid chromatographic assay coupled to fluorescence detection was developed for the detection of some angiotensin II receptor antagonists (ARA II): Losartan, Irbesartan, Valsartan, Candesartan cilexetil and its metabolite Candesartan MI. The analytes and the internal standard (bumetanide, a high-ceiling diuretic) were extracted from plasma under acidic conditions by means of solid-phase extraction using C8 cartridges. This procedure allowed recoveries close to 80% for all these drugs excluding Candesartan cilexetil (70%) which presented adsorption processes on glass and plastic walls. The analytes and potential interferences were separated on a reversed-phase column, muBondapak C18, at room temperature. A gradient elution mode was used to carry out the separation, the optimal mobile phase being composed of acetonitrile-5 mM acetate buffer, pH 4, at variable flow-rates (from 1.0 to 1.2 ml/min). Fluorescence detector was set at an excitation wavelength of 250 nm and an emission wavelength of 375 nm. Intra- and inter-day relative standard deviations for all the compounds were lower than 8% except for Losartan (12%) and the method assesses a quite good accuracy (percentage of relative error approximately 6% in most of the cases). The limit of quantitation for these compounds was 3 ng/ml for Candesartan cilexetil and M1, 16 ng/ml for Losartan and 50 ng/ml for Irbesartan and Valsartan, which allows their determination at expected plasma concentration levels. This assay method has been successfully applied to plasma samples obtained from hypertensive patients under clinical studies after oral administration of a therapeutic dose of some of these ARA II compounds.
    Journal of Chromatography A 04/2002; 949(1-2):49-60. · 4.61 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: A selective, accurate, precise and reproducible high-performance liquid chromatographic assay was developed for the quantitation of irbesartan, an angiotensin II antagonist, in human plasma and urine samples. The method involved solid-phase extraction of irbesartan and internal standard (I.S.) using a 100-mg Isolute CN cartridge. A portion of the eluate was injected onto an ODS analytical column connected to a fluorescence detector that was set at an excitation wavelength of 250 nm and an emission wavelength of 371 nm. The mobile phase consisted of 50% acetonitrile and a 50% weak phosphate-triethylamine solution, pH 3.5, at a flow-rate of 0.8 ml/min. The assay was linear from 1 to 1000 ng/ml with both plasma and urine. In either matrix, the lower limit of quantitation was 1 ng/ml. The analyses of quality control samples indicated that the nominal values could be predicted with an accuracy >95%. The inter- and intra-day coefficients of variation for the analyses in both matrices were <8%. Irbesartan was stable in both human plasma and urine for at least seven months at -20 degrees C. The application of the assay to a pharmacokinetic study is described.
    Journal of chromatography. B, Biomedical sciences and applications 11/1997; 702(1-2):149-55.
  • [Show abstract] [Hide abstract]
    ABSTRACT: A simple, selective, sensitive and precise high-performance liquid chromatographic plasma assay for the antihypertensive drugs, irbesartan and hydrochlorothiazide is described. Good chromatographic separation was achieved using a Supelcocil C(18) (5 micrometer 15 cmx4.6 mm) column and a mobile phase consisting of 10 mM potassium dihydrogen phosphate:methanol:acetonitrile (5:80:15 v/v/v) (pH:2.5) while at a flow-rate of 1.0 ml min(-1). Irbesartan and hydrochlorothiazide were detected at 275 nm and were eluted 5.8 and 7.8 min, respectively, after injection. No endogenous substances were found to interfere. The method utilizes protein precipitation with acetonitrile as the only sample preparation involved prior to reversed-phase high-performance liquid chromatography. No internal standard was required. Linearity range for irbesartan and hydrochlorothiazide was 10.0-60.0 microgram ml(-1) and 4.0-20.0 microgram ml(-1), respectively. The determination of intra- and inter-day precision (RSD) was less than 2.5 and 3.5%, at all concentration levels, while the inter- and intra-day accuracy (% difference) was less than 4.9-6.2%. This method is being used in a therapeutic drug monitoring service to quantitate these therapeutic agents in patients for pharmacokinetic studies.
    Journal of Chromatography B 02/2003; 784(1):195-201. · 2.49 Impact Factor

Full-text

View
80 Downloads
Available from
May 22, 2014