Development And Validation of a Simple, LCMS Compatible New Assay Method for The Simultaneous Estimation of Anti-Diabetic Drugs Metformin, Sitagliptin and Glimepiride

Tianeptine sodium is widely used as an antidepressant agent; hence it is used to treat depression and anxiety. Aim or Objective: Development of a stability-indicating HPTLC Method for the determination of Tianeptine Sodium in bulk and tablet Form. The objective of this study is to establish a simple, precise, and accurate stability-indicating high-performance thin-layer chromatography (HPTLC) method for the determination of tianeptine sodium in bulk and tablet dosage forms. Materials and Methods: The HPTLC method was developed using chromatographic plates pre-coated with silica gel G60 F254. The solvent system employed consisted of chloroform, acetone, and glacial acetic acid in the ratio of 7:3:0.1 (v/v/v). The optimized densitometric scanning was performed at a wavelength of 220 nm. Results: The Rf value for tianeptine sodium was found to be 0.32 ± 0.01. The method showed a good linear relationship, with an R² value of 0.9994, across the standard concentration range of 100–600 ng per spot. The developed method was determined to be precise, accurate, and cost-effective for the analysis of tianeptine sodium in both bulk and tablet dosage forms. Degradation peaks were identified during the degradation study. Conclusion: The study concluded that Tianeptine sodium is highly unstable under acidic conditions compared to other conditions. The developed method is simple, precise, accurate, and robust for the analysis of Tianeptine sodium. The degradation kinetics study revealed that tianeptine sodium follows pseudo-first-order kinetics in both acidic and basic conditions.