RP-HPLC Method Development and Validation for Lobeglitazone Sulfate in Bulk Pharmaceutical Tablet Dosage Form

Background: In bulk and tablet form, Lobeglitazone sulfate was evaluated utilizing a new, sensitive, accurate, and extremely precise reverse-phase high-performance liquid chromatography (RP-HPLC) technique was developed and validated.Objectives: This work focuses on the optimization of the stable (RP-HPLC) method for the measurement of lobeglitazone sulfate in Tablet Dosage form.Methods: The chromatographic separation was done at a temperature of 30°C using a 5μm, 250 x 4.6 mm RP analytical column. In an isocratic elution system, containing acetonitrile and water at a ratio of 70:30% v/v was used to separate the substances at a flow rate of 1.00 mL/min. A 248 nm wavelength was used for UV detection.Calibration curves for the analyte lobeglitazone sulfate showed linear concentration ranges of 10-50μg/mL, with correlation values equal to or above 0.9997. The duration of the detention period was reported as 5.427 minutes. Result: The process was validated according to ICH Q2 R1 criteria, assessed on many parameters such as linearity, accuracy, precision, specificity, limit of detection, limit of quantification, and robustness. Having a value of 0.9998, the linearity within the range of 10–50 μg/mL was strongly correlated. The relative standard deviation of the accuracy was found to be below 2%. Mean recovery rates varied between 100.50% and 101.01%. Limits of detection and quantification were determined to be 1.0 μg/mL and 0.4 μg/mL, respectively. A technique for calculating the appropriate dosage of lobeglitazone sulfate in tablet form has been devised.Conclusion: This method was tested for linearity, accuracy, precision, ruggedness,robustness, and recovery. A straightforward, accurate, sensitive, and cost-effective technique follows. This approach uses inexpensive, common mobile phase and chromatography. Based on the mobile phase, this approach quantifies pure Lobeglitazone sulfate and pharmaceutical Tablet formulations better.