Development and validation of a discriminating in vitro dissolution method for a poorly soluble drug, olmesartan medoxomil: comparison between commercial tablets.
A dissolution test for tablets containing 40 mg of olmesartan medoxomil (OLM) was developed and validated using both LC-UV and UV methods. After evaluation of the sink condition, dissolution medium, and stability of the drug, the method was validated using USP apparatus 2, 50 rpm rotation speed, and 900 ml of deaerated H(2)O + 0.5% sodium lauryl sulfate (w/v) at pH 6.8 (adjusted with 18% phosphoric acid) as the dissolution medium. The model-independent method using difference factor (f(1)) and similarity factor (f(2)), model-dependent method, and dissolution efficiency were employed to compare dissolution profiles. The kinetic parameters of drug release were also investigated. The obtained results provided adequate dissolution profiles. The developed dissolution test was validated according to international guidelines. Since there is no monograph for this drug in tablets, the dissolution method presented here can be used as a quality control test for OLM in this dosage form, especially in a batch to batch evaluation.
Bajerski
Lisiane
L
Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul, Av. Ipiranga, 2752, CEP 90610-000, Porto Alegre, RS, Brazil. lisianebajerski@yahoo.com.br
Rossi
Rochele Cassanta
RC
Dias
Carolina Lupi
CL
Bergold
Ana Maria
AM
Fröehlich
Pedro Eduardo
PE
D004353:Drug Evaluation, Preclinical / Q000379:methods*; D004355:Drug Stability; D007093:Imidazoles / Q000032:analysis / Q000737:chemistry*; D000068557:Olmesartan Medoxomil; D012995:Solubility; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods*; D013777:Tetrazoles / Q000032:analysis / Q000737:chemistry*
D007093:Imidazoles; D013607:Tablets; D013777:Tetrazoles; D000068557:Olmesartan Medoxomil