A Robust High-performance Thin-layer Chromatographic Method for the precise quantification of Lobeglitazone sulfate in Tablet Formulation

A tablet with a fixed dose of 0.5 mg lobeglitazone sulfate has been proven to effectively improve glycemic management in individuals with diabetes mellitus. The objective of this study was to develop and validate an efficient thin-layer chromatographic method for accurately measuring the amount of lobeglitazone sulfate in tablet form. The objective is to develop and validate a method, following the ICH recommendations, for precise quantification of lobeglitazone sulfate in tablet formulation. The analysis employed aluminium plates coated with silica gel 60F254 for high-performance thin-layer chromatography. The solvent system used was a mixture of toluene: ammonium acetate: acetonitrile and triethyl amine in a ratio of 4:2.5:1.5:0.2 v/v/v/v. The resulting chromatogram was then scanned at a wavelength of 248 nm using densitometry. The approach demonstrated a linear relationship in the range of 100-1500 ng/band for lobeglitazone sulfate, with correlation coefficient of 0.9991. Remarkable sensitivity was noted, with detection limits of 17.31 ng/band and quantification limits of 52.46 ng/band for lobeglitazone sulfate. The approach exhibited high precision, with a relative standard deviation of peak area below 2%. Additionally, it demonstrated accuracy, with a recovery rate ranging between 98% and 101%. The proposed methodology is suitable for measuring the specified drug in tablet formulations, making it useful for regular quality control evaluations in laboratories.