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@article{183478,
        author = {Padmanabh B. Deshpande and Ankit Rathod and Nikita Bhadane and Shreyas Raut},
        title = {Development and Validation of Stability-indicating HPTLC for Determination of Imeglimin Hydrochloride as Bulk Drug and in Tablet Formulation},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {12},
        number = {3},
        pages = {1836-1839},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=183478},
        abstract = {A simple, precise, and sensitive stability-indicating High-Performance Thin Layer Chromatography (HPTLC) method was developed and validated for quantitative estimation of Imeglimin hydrochloride as bulk drug and in tablet formulation. The separation was achieved on precoated silica gel 60 F254 TLC plates using Chloroform: Ethyl acetate: Methanol (6: 1.5: 2.5, v/v/v) as the mobile phase. Densitometric scanning was performed at 241 nm. Forced degradation studies revealed the susceptibility of Imeglimin under all analyzed stress conditions. The method that was optimized has been inspected for linearity, accuracy, precision, limit of detection, limit of quantification, and robustness according to ICH guidelines. The developed method exhibited good linearity over a concentration range of 200-1200 ng band-1 with correlation coefficient (R²) of 0.996. Limit of detection and quantitation were found to be 14.54 ng band-1 and 44.07 ng band-1, respectively. The % drug content in commercial tablets was determined with satisfactory recovery values and %RSD <2.0, fulfilling ICH guidelines. This validated method is suitable for routine quality control analysis of Imeglimin hydrochloride.},
        keywords = {Imeglimin hydrochloride, HPTLC, Stability Studies, Validation},
        month = {August},
        }