Drug dissolution studies and determination of rosiglitazone maleate in tablets and polymeric microspheres by a rapid, validated RP-HPLC method

作者：Kamila Madan Mohan; Mondal Nita; Ghosh Lakshmikanta^*; Gupta Bijan Kumar

来源：Journal of Liquid Chromatography & Related Technologies, 2008, 31(16): 2503-2516.

DOI：10.1080/10826070802319800

• dissolution
• kinetic model
• polymeric microspheres
• rosiglitazone maleate
• RP-HPLC
• validation

A rapid and validated RP-HPLC method with UV detection has been developed to determine rosiglitazone maleate in raw material, pharmaceuticals, and in-vitro drug dissolution studies. The analysis was carried out using a reversed phase C8 column (250 mm x 4.6 mm) and a mobile phase composed of acetonitrile: methanol: acetate buffer (30:20:50v/v/v). The method was validated according to the ICH guidelines. The method produced linear response over the range of 5-100 mu g mL(-1). The method was successfully applied for the determination of the drug in tablet dosage form, polymeric microspheres, and in-vitro drug dissolution. No interference was observed from the excipients of tablets, microspheres, and drug dissolution studies.

• 出版日期2008