Background: For the treatment of diabetes mellitus type 2, a new formulation containing
vildagliptin and remogliflozin was developed. A simple and rapid RP-HPLC method
employing linagliptin as an internal standard was developed for quality control of this
medicine. Methodology: Formulation analytes, including IS, were separated on a Zorbax
C18 column with isocratic elution of acetonitrile and phosphate buffer (pH 5) 55:45 v/v
at a flow rate of 1.2 mL/min. The experiment was carried out at room temperature and
monitored at a wavelength of 210 nm. The approach was also validated in accordance
with the ICH Q2 requirements. Results: The optimized HPLC approach revealed a
satisfactory linearity in the concentration ranges of 10-60 μg/mL and 10-100 μg/mL for
VIL and REM respectively, with good regression coefficient (
R2≥0.998). The average
accuracy for VL and REM was 99.57 percent and 100.59 percent, respectively, with a
low percentage relative error. The method’s precision was proven by the low percentage
relative standard deviation. Furthermore, a robustness assessment employing a Pareto
chart generated using a three-level factor interaction study, a multivariate technique,
demonstrated that minor changes in individual experimental conditions had no effect
on the test results. Finally, the optimized HPLC method was effectively used to assess
VIL and Rem from formulation simultaneously. Conclusion: The findings of an assay
comparing a simple and rapid isocratic RP-HPLC method devised for the simultaneous
quantification of VIL and REM to a previously published approach revealed no significant
differences in the assay results. As a result, it might be utilized in any analytical laboratory
for quality control of this formulation.