Development and Validation of a New Stability-Indicating HPLC Method for the Determination of Rosiglitazone in Tablets

Abstract

Rosiglitazone (ROS) is an antidiabetic drug belonging to the thiazolidine class. A new stability-indicating high-performance chromatographic (HPLC) method was developed for the determination of ROS in pharmaceuticals, and validated for its suitability following the ICH guidelines. Chromatography was performed on a Chromatopack (250×4.6 mm; 5 µm particle size) column using phosphate buffer of pH 3.2 and methanol (70:30 v/v) as mobile phase pumped at a flow rate of 1 ml min^-1 with UV-detection at 220 nm. The influences of mobile phase composition, buffer pH, flow rate and column temperature on the retention behaviour of the analyte were carefully studied and optimized. Quantification was based on peak area measurement and mean peak area-concentration plot was linear (r = 0.9999) over 7–525 µg mL^-1 concentration range. Robustness of the method was assessed by performing the analysis under slightly altered chromatographic conditions; whereas ruggedness was determined with analysis being done by different analysts using different columns. The method was found to be selective as shown by results of placebo and synthetic mixture analyses. The method was applied to the determination of ROS in tablets and the results agreed well with the label claim and those obtained by a reference method. As part of degradation study, ROS was subjected to forced degradation under acid, base, oxidant, heat and light-induced stress conditions, and the results indicated that the drug was susceptible to base and oxidant-induced stress conditions and inert to other stress conditions.

Keywords: Rosiglitazone, determination, HPLC, pharmaceuticals, stability-indicating

Cite this Article

Basavaiah K, Rajendraprasad N. Development and Validation of a New Stability-Indicating HPLC Method for the Determination of Rosiglitazone in Tablets. Research and Reviews: A Journal of Pharmaceutical Science. 2017; 8(1): 1–9p.