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Type: Artigo de periódico
Title: Simultaneous determination of clobutinol hydrochloride and doxylamine succinate from syrups by RP HPLC using a new stationary phase containing embedded urea polar groups
Author: Rosa, PCP
Jardim, ICSF
Abstract: A new, simple, fast, reproducible and sensitive reversed phase HPLC method, using a new stationary phase containing embedded urea polar groups, has been developed and validated for the simultaneous determination of clobutinol hydrochloride (CLO) and doxylamine succinate (DOX) in syrups. The determination was carried out on a C8 urea column (125 mm x 3.9 mm id., 5 mu m particle size) synthetized at the Liquid Chomatography Laboratory (LabCrom) of the Chemistry Institute of Unicamp. The mobile phase consisted of a mixture of acetonitrile:methanol:phosphate buffer (pH 2.5) in the gradient mode. The diode array detector (DAD) was operated at 230 nm for CLO and 262 nm for DOX. The method showed adequate precision, with relative standard deviations (RSD) less than 1%. The presence of the excipients did not interfere in the results of the analysis. Accuracy was determined by adding standards of the drugs to a placebo and good recovery values were obtained. The analytical curves were linear (r(2) 0.9999 for CLO and 0.9998 for DOX) over a wide concentration range (2.4-336 mu g mL(-1) for CLO and 2.3-63 mu g mL(-1) for DOX). The solutions were stable for at least 72 hours at room temperature. The criteria for validation using the ICH guidelines were fulfilled.
Subject: Clobutinol hydrochloride/determination
Doxylamine succinate/determination
High performance liquid chromatogralhy/quantitative analysis
Country: Brasil
Editor: Univ Sao Paulo, Conjunto Quimicas
Citation: Brazilian Journal Of Pharmaceutical Sciences. Univ Sao Paulo, Conjunto Quimicas, v. 48, n. 2, n. 315, n. 323, 2012.
Rights: aberto
Date Issue: 2012
Appears in Collections:Unicamp - Artigos e Outros Documentos

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