Abstract
A simple reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated of rosiglitazone in bulk and tablet dosage form. Chromatographic analysis was performed on a C18 column (250x 4.6 mm, 5µm) with a mixture of Ammonium dihydrogen phosphate buffer (pH 4.5) : Acetonitrilein the ratio 65:35 as mobile phase, at a flow rate of 1.0 mL min−1. UV detection was performed at 230 nm. The method was validated for accuracy, precision, specificity, linearity, and sensitivity. The  retention times of  rosiglitazone was found to be 7.19±0.145 respectively. Linearity was obsered in concentration ranges of 12–70 µg mL−1. The limit of detection was 0.725 and the quantification limit was 2.41 µg/ml . The accuracy of the proposed method was determined by recovery studies and found to be 98.26% to 101.37%. Commercial tablet formulation was successfully analyzed using the developed method and the proposed method is applicable to routine analysis of determination of rosiglitazone and in bulk and tablet dosage form.
Highlights
IntroductionRosiglitazone is a thiazolidinedione derivative and it is used for the treatment of type 2 diabetes mellitus, chemically it is 5-[[4-[2-(5-
Rosiglitazone is a thiazolidinedione derivative and it is used for the treatment of type 2 diabetes mellitus, chemically it is 5-[[4-[2-(5-ethylpyridin-2-yl) ethoxy] phenyl] methyl]-1, 3-thiazolidine-2, 4-Dione
Simultaneous LC-ESI-MS method for estimation of rosigliazone and Ndesmethyl rosiglitazone in human plasma[10]. These methods are sophisticated, expensive and time consuming when compared to simple HPLC method
Summary
Rosiglitazone is a thiazolidinedione derivative and it is used for the treatment of type 2 diabetes mellitus, chemically it is 5-[[4-[2-(5-. Simultaneous LC-UV estimation of rosigliazone and glimepiride in plasma[8], rosigliazone and glimepiride in human plasma[9]. Simultaneous LC-ESI-MS method for estimation of rosigliazone and Ndesmethyl rosiglitazone in human plasma[10]. These methods are sophisticated, expensive and time consuming when compared to simple HPLC method. There is need for a interest to develop simple, accurate, specific, sensitive, precise and reproducible HPLC method for the estimation of rosiglitazone in bulk and its formulation. Materials and Methods: Pure standard of rosiglitazone (Assigned purity 99.98%) was obtained as a gift sample from Micro labs Pvt. Ltd, Badi, India. The chemical structure and purity of the sample obtained was confirmed by TLC, IR, Melting point studies
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