Development and validation of an analytical method by RP-HPLC for quantification of sibutramine hydrochloride in pharmaceutical capsules
Contribuinte(s) |
Universidade Estadual Paulista (UNESP) |
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Data(s) |
20/05/2014
20/05/2014
01/04/2011
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Resumo |
Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) Sibutramine is a monoamine re-uptake inhibitor used for the treatment of obesity. In the present study a rapid, sensitive and economical HPLC method was developed and fully validated for analysis of sibutramine HCl in pharmaceutical capsules. HPLC analyses were carried out by using an isocratic elution mode with a mobile phase constituted by sodium phosphate buffer (pH 2.5) and methanol (30 : 70, v/v), flow rate at 1.0 mL min(-1), column temperature at 40 degrees C, UV detection wavelength at 225 nm and 20 mu L of injection volume. The validation parameters were in accordance with FDA and ICH specifications, showing accuracy, precision, selectivity, robustness and linearity from 4.5 to 19.5 mg L(-1) of sibutramine HCl. The limits of detection and quantification were 0.666 and 2.018 mg L(-1), respectively. The validated method is suitable for quality control applications and its advantages over the already existing methods are simplicity and reduced analysis time. |
Formato |
985-990 |
Identificador |
http://dx.doi.org/10.1039/c0ay00598c Analytical Methods. Cambridge: Royal Soc Chemistry, v. 3, n. 4, p. 985-990, 2011. 1759-9660 http://hdl.handle.net/11449/7918 10.1039/c0ay00598c WOS:000292164200029 WOS000292164200029.pdf |
Idioma(s) |
eng |
Publicador |
Royal Soc Chemistry |
Relação |
Analytical Methods |
Direitos |
closedAccess |
Tipo |
info:eu-repo/semantics/article |