Objective: The objective of the present study is to develop and validate a simple, rapid stability indicating high performance liquid chromatography method for the simultaneous quantification of metformin, empagliflozin, linagliptin in bulk and pharmaceutical dosage form.
Materials And Methods: The chromatographic separation was achieved on C18 X-bridge phenyl column (250×4.6mm, 5μm particle size). The pharmaceutical analytes were quantified by diode array detector in HPLC, eluted with acetonitrile and triethylamine (70:30) as mobile phase, monitored at 240nm over a runtime of 7min.
Results: The method was linear in the range of 50-750μg/mL (r=0.999) for metformin, 0.5-7.5μg/mL (r=0.999) for empagliflozin, 0.25-3.75μg/mL (r=0.999) for linagliptin. The percentage recoveries of these 3 drugs were within acceptable limits (99.2-100.8). The method was found to be precise as % RSD<2. Forced degradation studies were conducted under acidic, basic, oxidative, reductive, photolysis, thermal conditions and showed degradation within (19.4-32.4%).
Conclusion: The validated (as per ICH guidelines) rapid method can be routinely used in quality control lab for the quantification of metformin, empagliflozin and linagliptin in raw materials as well as in pharmaceutical dosage form.
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