Method Development and Validation for Estimation of Lobeglitazone Sulfate in Bulk and Oral Solid Dosage Form by Chromatographic Technique

Background: Lobeglitazone, a recently discovered thiazolidinedione, offers a superior and more efficient option compared to current TZDs. The literature review reveals that only a limited number of bioanalytical and analytical methodologies have been published so far for the quantification of Lobeglitazone in pharmaceutical formulations. Objectives:A novel, simple, specific, and accurate RP-HPLC technique was developed to quantify the amount of Lobeglitazone Drug in both bulk and oral solid dosage forms. Materials and Methods: The separation was conducted utilising an Inertsil-OSD C18 column with dimensions of 250 cm in length, 4.6 mm in diameter, and a particle size of 5 μm. The mobile phase comprised a blend of Methanol and acetonitrile at a volumetric ratio of 85:15. The pH of the mobile phase was modified to 4.0 by utilising orthophosphoric acid. The flow rate was set at 1.0 mL/min, and the effluents were measured at a wavelength of 271 nm. Results:The retention time of Lobeglitazone was measured to be 3.519 minutes. The drug demonstrated a linear relationship within the concentration range of 20-70 μg/mL, with a correlation value of 0.999. The limit of detection (LOD) and limit of quantification (LOQ) were determined to be 0.0026 μg/mL and 0.0081 μg/mL, respectively. The method's accuracy was deemed good, with the mean recovery percentage being within the acceptable range of 99.92-100.33%. Conclusion:The HPLC technique was effectively established and verified in accordance with the ICH recommendations. The suggested technique demonstrated simplicity, precision, sensitivity, rapidity, and robustness in estimating Lobeglitazone in both bulk and tablet dose forms.