Development and Validation of an HPLC Method for the Determination of Lobeglitazone in Bulk and in Tablet Formulation

Objectives: A straightforward, accurate, and precise reverse-phase high-performance liquid chromatography method was developed to determine the quantity of Lobeglitazone in both bulk and pharmaceutical dosage forms. Materials and Methods: The chromatographic separation was achieved on a Phenomenex Luna column with dimensions of 250 cm×4.6 mm×5 μm, and the mobile phase was a combination of potassium dihydrogen orthophosphate and acetonitrile in a 70:30 V/V ratio with a pH of 4.0, adjusted using orthophosphoric acid. The flow rate was set at 1.0 mL/min, and detection of the effluents occurred at 250 nm. Results: The retention time for Lobeglitazone was determined to be 2.157 min. The drug exhibited linearity within the concentration range of 10-60 μg/mL, the correlation coefficient was established to be 0.9996. The LOD, LOQ were found to be 0.8 μg/mL and 2.5 μg/mL. The accuracy of the method was considered satisfactory and the mean recovery percentage is found to be in the acceptable range of 99.78-101.31%. Conclusion: The HPLC method was successfully developed, validated as per ICH guidelines. The proposed method was simple, precise, sensitive, rapid, robust for the estimation of Lobeglitazone in both bulk and tablet dosage forms.