Two New, Useful and Facile Stability-Indicating UV Spectrophotometric Methods for the Determination of Rosiglitazone in Pharmaceuticals

Abstract

Rosiglitazone (ROS) is an antidiabetic drug belonging to the thiozolidine class. Two simple, rapid, sensitive, accurate and reproducible UV-spectrophotometric methods were developed and subsequently validated for the determination of ROS in bulk and tablet form. The methods are based on the measurement of the absorbance of the drug solution either in 0.1 M NaOH (NaOH method) or in 0.1 M HCl (HCl method) at 316 nm in both instances. The developed methods were validated for several parameters as per the ICH guidelines. Beer’s law was obeyed over the concentration ranges 4–72 µg ml-1and 2.5–45.0 µg ml-1, for both NaOH and HCl diluents, respectively, with corresponding molar extinction coefficients of 4.61 × 103 and 7.32 × 103 l mol-1 cm-1. The calculated limits of detection (LOD) and limits of quantification (LOQ) were 0.44 and 1.33 µg ml-1 (NaOH method) and 0.28 and 0.86 µg ml-1 (HCl method), respectively. The intraday and interday percent RE values, reflective of accuracy, were <2%; and the methods were also found to be repeatable and reproducible with %RSD values of <2%. Results of robustness and ruggedness were satisfactory. The methods were also shown to be selective as seen from the results of placebo and synthetic mixture analyses. When applied to tablets, results obtained were comparable with the label claim as well as those obtained by a reference method. As part of stress testing, the drug was subjected to forced degradation under the recommended stress conditions of ICH, and it was found to undergo substantial degradation under base hydrolysis and oxidation-induced stress conditions, but remained inert to acid hydrolysis, photolytic- and heat-induced stress conditions, thereby reflecting the stability-indicating ability of the methods.  Keywords: Rosiglitazone, determination, UV-spectrophotometry, pharmaceuticals, stabilityindicating  Cite this Article Basavaiah K, Rajendraprasad N. Two New, Useful and Facile StabilityIndicating UV Spectrophotometric Methods for the Determination of Rosiglitazone in Pharmaceuticals. Research and Reviews: A Journal of Pharmaceutical Science. 2017; 8(2):   8–19p.