Abstract
The current study focuses on developing and validating a reverse phase-high performance liquid chromatography (RP-HPLC) method for quantifying metformin HCL (MET) and alogliptin (ALO) in both dosage and bulk drug forms. ALO and MET in tablet form were determined simultaneously using an RP-HPLC technique. The Reverse Phase (Waters) C18 (4.6 mm x 150 mm; 5 µ) column, a 20-injection loop are the components of the gradient system for the RP manufactured by Agilent Technologies. In the procedure, a 50:50 volumetric combination of methanol and water (0.1% acetic acid) was used as the mobile phase at pH 4.5. The developed approach yielded retention times of 3.856 minutes for MET and 6.302 minutes for ALO. The reliability of the established technique was demonstrated in compliance with the International Council of Harmonization (ICH) standards. In general, all of the metrics including linearity, accuracy, range, and robustness, were found to be within the acceptable ranges. Consequently, the methodology was assessed to be simple, precise, cost-effective, and replicable. Hence, the analysis of MET and ALO in both bulk medication and formulated states can be regularly conducted utilising the procedures specified for the purpose of quality control.
Published Version
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