QBD- Guided RP-HPLC Method Development and validation of Lobeglitazone Sulphate

This study focused on developing and validating a method for analyzing Lobeglitazone using RP-HPLC based on Quality by Design (QbD). A 2FI factorial design identified and optimized key variables, including the mobile phase composition (% Acetonitrile) and flow rate. Water and acetonitrile were used as the mobile phase in an isocratic separation on a C18 column. We set the detection wavelength for medication at 248 nm. During the validation process, we examined parameters such as specificity, linearity, precision, accuracy, robustness, LOD, and LOQ, following ICH Q2(R1) guidelines. The method produced a clear, well-defined peak for Lobeglitazone, with a retention time within acceptable limits. Linearity was confirmed over a concentration range of 5-25 µg/ml for LBZ analysis, with correlation coefficients (R²) of 0.999 for both compounds, indicating a strong linear response. The method showed high accuracy with recovery rates between 98 and 102%, while precision displayed %RSD values below 2%. The LOD and LOQ values confirmed the method's sensitivity. ANOVA showed that both the mobile phase and flow rate significantly affected retention time, theoretical plates, and tailing factors. We observed no interference in blank chromatograms, ensuring specificity. The method remained robust against minor intentional changes in chromatographic conditions. This research developed a QbD-based RP-HPLC method that is straightforward, accurate, precise, and reliable for simultaneously estimating LBZ. The method is suitable for routine quality control and stability testing of pharmaceutical products.