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...

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Bibliographic Details
Published in:AAPS PharmSciTech 2010-06, Vol.11 (2), p.637-644
Main Authors: Bajerski, Lisiane, Rossi, Rochele Cassanta, Dias, Carolina Lupi, Bergold, Ana Maria, Fröehlich, Pedro Eduardo
Format: Article
Language:English
Subjects:
Biochemistry
Biomedical and Life Sciences
Biomedicine
Biotechnology
Drug Evaluation, Preclinical - methods
Drug Stability
Imidazoles - analysis
Imidazoles - chemistry
Indexing in process
Olmesartan Medoxomil
Pharmacology/Toxicology
Pharmacy
Research Article
Solubility
Tablets
Technology, Pharmaceutical - methods
Tetrazoles - analysis
Tetrazoles - chemistry
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Summary: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.
ISSN:1530-9932
1530-9932
DOI:10.1208/s12249-010-9421-0