Abstract:
: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.
journal_name
AAPS PharmSciTechjournal_title
AAPS PharmSciTechauthors
Bajerski L,Rossi RC,Dias CL,Bergold AM,Fröehlich PEdoi
10.1208/s12249-010-9421-0subject
Has Abstractpub_date
2010-06-01 00:00:00pages
637-44issue
2issn
1530-9932journal_volume
11pub_type
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