Discriminative Dissolution Method for Benzoyl Metronidazole Oral Suspension.
A dissolution method for benzoyl metronidazole (BMZ) oral suspensions was developed and validated using a high-performance liquid chromatography (HPLC) method. After determination of sink conditions, dissolution profiles were evaluated using different dissolution media and agitation speeds. The sample insertion mode in dissolution media was also evaluated. The best conditions were obtained using a paddle, 50 rpm stirring speed, simulated gastric fluid (without pepsin) as the dissolution medium, and sample insertion by a syringe. These conditions were suitable for providing sink conditions and discriminatory power between different formulations. Through the tested conditions, the results can be considered specific, linear, precise, accurate, and robust. The dissolution profiles of five samples were compared using the similarity factor (f 2) and dissolution efficiency. The dissolution kinetics were evaluated and described by the Weibull model. Whereas there is no monograph for this pharmaceutical formulation, the dissolution method proposed can be considered suitable for quality control and dissolution profile comparison of different commercial formulations.
Department of Pharmacy, Federal University of Pampa, BR 472 Km 592, Uruguaiana, RS, 97500-970, Brazil. alinesilva@unipampa.edu.br.
Aline Santos
http://orcid.org/0000-0001-8579-7941
AS
da Silva
Department of Pharmacy, Federal University of Pampa, BR 472 Km 592, Uruguaiana, RS, 97500-970, Brazil.
Carlos Eduardo
CE
da Rosa Silva
Department of Pharmacy, Federal University of Pampa, BR 472 Km 592, Uruguaiana, RS, 97500-970, Brazil.
Fávero Reisdorfer
FR
Paula
Department of Pharmacy, Federal University of Pampa, BR 472 Km 592, Uruguaiana, RS, 97500-970, Brazil.
Fabiana Ernestina Barcellos
FE
da Silva
D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D008795:Metronidazole / Q000031:analogs & derivatives* / Q000737:chemistry / Q000493:pharmacokinetics; D010316:Particle Size; D012995:Solubility
C035348:benzoylmetronidazole; D008795:Metronidazole
benzoyl metronidazole; dissolution test; liquid chromatography; oral suspension