Abstract
Background: Type 2 diabetes mellitus is an expanding health problem. Binary antidiabetic combinations of Metformin Hydrochloride (MET) with either Saxagliptin Hydrochloride (SAX), or Dapagliflozin (DAP) are widely used. Review of the literature revealed that no single HPTLC method has been reported for the simultaneous determination of MET, SAX, and DAP allowing the determination of binary mixtures of any two of the three cited drugs in their tablets using the same experimental conditions, an important advantage for quality control. The advantages of HPTLC method relies on the simultaneous analysis of a large number of samples in a shorter analysis time, less solvent consumption, and less expenses, compared with HPLC.
Objective: The objective of the proposed method is to develop and validate a single and simple HPTLC densitometric method for the simultaneous determination of MET, SAX, and DAP.
Methods: Separation was performed using aluminum HPTLC sheets coated with silica gel 60 F254 with a mobile phase consisting of a mixture of acetonitrile: 1% w/v ammonium acetate in methanol (9: 1, v/v). Scanning was performed at 210 nm.
Results and Discussion: Linearity of the method was assessed in the concentration range of 0.25-10 mu g/band for SAX and DAP and 0.25-25 mu g/band for MET. The method was fully validated as per the ICH guidelines. The proposed method provided error and deviation values of less than 2% assessing good accuracy and precision.
Conclusion: The method was successfully applied to the analysis of pharmaceutical tablets of MET/SAX, MET/DAP, and SAX/DAP with high specificity.