Drug Dissolution Studies and Determination of Rosiglitazone Maleate in Tablets and Polymeric Microspheres by a Rapid, Validated RP-HPLC Method

Abstract

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 × 4.6 mm) and a mobile phase composed of acetonitrile: methanol: acetate buffer (30:20:50 v/v/v). The method was validated according to the ICH guidelines. The method produced linear response over the range of 5–100 µg 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.

Keywords:

• Dissolution
• Kinetic model
• Polymeric microspheres
• Rosiglitazone maleate
• RP-HPLC
• Validation

Notes

∗Column efficiency is expressed in terms of number of theoretical plates.

∗Drug content is calculated on theoretical basis.

∗∗indicates drug encapsulation efficiency of prepared microspheres.

∗k _r, Release rate constant of first order kinetic; k _r0, Release rate constant of zero order kinetics; k _HC , Release rate constant of Hixson-Crowell kinetics; k _H, Release rate constant of Higuchi kinetics; k _p, Release constant of Peppas equation; r ², Determination coefficient; n, Diffusional exponent.