Quantification of Lobeglitazone Sulfate in Bulk and Tablet Dosage Form by a Validated UV Spectroscopy Method: A New Thiazolidinedione Anti-diabetic Drug

Abstract

Background: Lobeglitazone sulfate is a novel thiazolidinedione drug used for the therapy of type 2 diabetes. Recent pre-clinical studies show that the drug is also effective in attenuating mucus hypersecretion and airway inflammation caused due to ovalbumin-induced asthma. Objective: This study aimed to develop an accurate, simple, and cost-effective analytical method for the quantification of lobeglitazone sulfate in bulk and pharmaceutical dosage forms by UV spectrophotometric technique. Methods: The drug was identified by FTIR (ATR) instrument and the method development was performed with methanol as the solvent. In compliance with the ICH Q2(R2) guidelines, all the important validation parameters, such as linearity, accuracy, Limit of Detection (LOD), precision, specificity, Limit of Quantification (LOQ), and robustness were deter-mined. Results: The maximum absorption wavelength of lobeglitazone sulfate was found to be 248 nm. The linearity range was established from 2-14 μg/mL with a linearity equation of y = 0.0361x + 0.0024 and r² = 0.9987. The accuracy of the analytical method was found to be in the range of 99.37-100.41%. The precision studies were performed under three subsets of re-peatability, intra-day, and inter-day, and the results recorded were within the acceptance lim-its, i.e., %RSD (<2%). The developed analytical method's Limit of Detection (LOD) and Limit of Quantification (LOQ) values were 0.07 μg/mL and 0.22 μg/mL, respectively. Conclusion: The developed analytical method has been found to be valuable in regular qual-ity control analysis of lobeglitazone sulfate in pharmaceutical industries. The adopted ap-proach of the developed method has been found to be facile, accurate, precise, and economi-cal.