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

被引：3

作者：

Kamila, Madan Mohan ^{[1
]}

Mondal, Nita ^{[1
]}

Ghosh, Lakshmikanta ^{[1
]}

Gupta, Bijan Kumar ^{[1
]}

机构：

[1] Jadavpur Univ, Dept Pharmaceut Technol, Div Pharmaceut, Kolkata 700032, India

来源：

JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES | 2008年 / 31卷 / 16期

关键词：

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

D O I：

10.1080/10826070802319800

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

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.

引用

页码：2503 / 2516

页数：14

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