DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR SIMULTANEOUS DETERMINATION OF LINAGLIPTIN AND METFORMIN

Objective: A simple, precise, and accurate stability indicating high-performance thin-layer chromatography (HPTLC) method was developed and validated for simultaneous estimation of linagliptin and metformin active pharmaceutical ingredients and fixed dose combination.Methods: Linagliptin and metformin densitograms were developed on silica gel 60 F254 HPTLC plates with acetone: methanol: chloroform: formic acid (3:1:5:1v/v) as the mobile phase. Densitometric quantification was performed at 230 nm.Results: For linagliptin and metformin RF values were found as 0.72 and 0.19, respectively. The method was validated for precision, accuracy, specificity, and robustness. The linearity curves were obtained in the concentration range of 100–600 ng per spot by area with correlation coefficients of 0.999 and 0.99 for linagliptin and metformin, respectively. Limit of detection was found to be 5.19 and 8.72 ng per spot for linagliptin and metformin, respectively; lowest possible quantity to be quantified by the proposed method was found to be 15.74 and 26.44 ng per spot for linagliptin and metformin, respectively. From stability studies, the noninterference of the linagliptin and metformin degradants with drugs demonstrated the suitability of the developed method.Conclusion: The developed method was validated and found to be selective, specific and suitable for application in pharmaceutical analysis of these drugs in bulk and fixed dose combination.Â