Green methods for the simultaneous analysis of pharmaceutical mixtures present in disparate concentration ranges: Application to antidiabetic mixtures

Diabetes-mellitus is one of the most common chronic diseases worldwide. Today, many single-pill combinations exist and are indicated especially for diabetic patients who are unable to achieve sufficient glycemic-control with one active component. However, some of these combinations are formulated in concentration ratios that present a real challenge for their analysis and quality-control assessment. For instant, linagliptin (L) and saxagliptin (S) are two oral dipeptidylpeptidase-4 inhibitors that have recently been formulated with metformin (M) in a ratio of 1:400 with almost no simple analytical methods offered in literature for their analysis in such disparate concentration-ratio. In this study, a simple, fast and green capillary electrophoretic (CE) method was established for the simultaneous determination of L and S with M in pharmaceutical-dosage-forms. The developed method was linear in the range of 2?200 ?g.mL-1 for L and S and 10?2000 ?g.mL-1 for M with r > 0.9993 with low LOD and LOQ values that allowed the proposed method to be successfully applied for the sensitive determination of S, L and M in their binary-combinations of S-M and L-M in pharmaceutical-dosage-forms despite the large differences in M and L or S doses. Upon comparison with the few reported-methods, the proposed-method offers the advantages of high separation efficiency and low solvent consumption. In addition to using simple aqueousbuffer that adds to the greenness of the method and decrease the cost of operation. The Eco-scale penalty points approach and the Green Analytical Procedure Index were applied to assess the greenness of the developed method. Results revealed that the proposed method is a greener alternative to the reported ones This allows our proposed-method to be used for the routine high-through-put analysis required in quality-control laboratories as an efficient and simple eco- friendly analytical-tool.

Automated summary

Diabetes mellitus is a common chronic disease, often requiring combination therapy for glycemic control. A study established a simple and green method using capillary electrophoresis for the simultaneous determination of certain drugs in pharmaceutical forms. This method showed high separation efficiency and low solvent consumption, making it a green and cost-effective option for quality control analysis.