Estimation of Rosiglitazone in Bulk and Tablet Dosage Forms by HPTLC Method.

A simple and sensitive, HPTLC method has been developed for the quantitative estimation of rosiglitazone in its single component tablet formulations (4 mg). Rosiglitazone was chromatographed on silica Gel 60 F₂₅₄TLC plate using Toluene:acetone: ammonia (4.5:5.5:0.1 v/v) as mobile phase. Rosiglitazone showed Rf value 0.55±0.03 and scanned at 318 nm using Camag TLC Scanner 3. The method was validated in terms of linearity (200–2000 ng/spot), precision (intra-day variation 0.6 to 3.6%, inter-day variation 0.6 to 3.0%), accuracy (98.1 to 103.3%) and specificity. The limit of detection and limit of quantification for rosiglitazone were found to be 30 ng/spot and 100 ng/spot, respectively. The developed method was successfully used for the assay of rosiglitazone tablet formulations. The method is simple, sensitive and precise; it can be used for the routine quality control testing of marketed formulations.