Development and validation of a dissolution method using HPLC for diclofenac potassium in oral suspension

Autor:	Alexandre Machado Rubim, Jaqueline Bandeira Rubenick, Luciane Varini Laporta, Clarice Madalena Bueno Rolim
Jazyk:	angličtina
Rok vydání:	2014
Předmět:	Método de dissolução/desenvolvimento Método de dissolução/validação Diclofenaco potássico/liberação em suspensão oral Suspensão oral/controle de qualidade Cromatografia líquida de alta eficiência/análise qualitativa Pharmacy and materia medica RS1-441
Zdroj:	Brazilian Journal of Pharmaceutical Sciences, Vol 50, Iss 2, Pp 423-429 (2014)
Druh dokumentu:	article
ISSN:	2175-9790 1984-8250
DOI:	10.1590/S1984-82502014000200022
Popis:	The present study describes the development and validation of an in vitro dissolution method for evaluation to release diclofenac potassium in oral suspension. The dissolution test was developed and validated according to international guidelines. Parameters like linearity, specificity, precision and accuracy were evaluated, as well as the influence of rotation speed and surfactant concentration on the medium. After selecting the best conditions, the method was validated using apparatus 2 (paddle), 50-rpm rotation speed, 900 mL of water with 0.3% sodium lauryl sulfate (SLS) as dissolution medium at 37.0 ± 0.5°C. Samples were analyzed using the HPLC-UV (PDA) method. The results obtained were satisfactory for the parameters evaluated. The method developed may be useful in routine quality control for pharmaceutical industries that produce oral suspensions containing diclofenac potassium.
Databáze:	Directory of Open Access Journals
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