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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. [ABSTRACT FROM AUTHOR]

Background: An anti-diabetic formulation consisting of vildagliptin and remogliflozin was prescribed for better glycemic control. In the present study a simple, rapid derivative spectrophotometric methods were evolved to analyze these two analytes from the formulations. Methods: Two processed UV spectrophotometric methods were established by measuring the peak amplitude at zero-crossing of second derivative spectra of analytes. The second procedure comprehends the generation of zero - order spectra from the mixture of analyte spectra by division and multiplication by the pure analyte spectra to remove the effect of one of the analytes. Results: Both methods showed linearity concentrations in the range of 2-75 µg/ml for RGF and 2-50 µg/ml for VGT. The low LOD and LOQ found for RGF and VGT by both methods indicated the good sensitivity of the methods. The mean percentage recovery was 98.60 % and 100.78%, for RGF and 98.81 % and 99.15 % for VGT, with low percent relative error. The % RSD for intra and inter-day precision was less than ±2%. Finally, the planned methods were employed for the assay of the VGT and RGF from the medicine and the outcomes were matched with the reported methods. Conclusion: The assay results of the formulation were in agreement with the concentration of labeled amount and no significant difference was observed in the results when compared to the reported method. Hence, the anticipated procedures could be applied for the routine quality control of formulations consisting of VGT and RGF. [ABSTRACT FROM AUTHOR]

Three rapid, accurate, and ecofriendly processed spectrophotometric methods were validated for the concurrent quantification of remogliflozin (RGE) and vildagliptin (VGN) from formulations using water as dilution solvent. The three methods developed were based on the calculation of the peak height of the first derivative absorption spectra at zero-crossing points, the peak amplitude difference at selected wavelengths of the peak and valley of the ratio spectra, and the peak height of the ratio first derivative spectra. All three methods were validated adapting the ICH regulations. Both the analytes showed a worthy linearity in the concentration of 1 to 60 µg/mL and 2 to 90 µg/mL for VGN and RGE, respectively, with an exceptional regression coefficient (r2 ≥ 0.999). The developed methods demonstrated an excellent recovery (98.00% to 102%), a lower percent relative standard deviation, and a relative error (less than ±2%), confirming the specificity, precision, and accuracy of the proposed methods. In addition, validated spectrophotometric methods were commendably employed for the simultaneous determination of VGN and RGE from solutions prepared in the laboratory and the formulation. Hence, these methods can be utilized for the routine quality control study of the pharmaceutical preparations of VGN and RGE in pharmaceutical industries and laboratories. The ecofriendly nature of the anticipated spectrophotometric procedures was confirmed by the evaluation of the greenness profile by a semi-quantitative method and the quantitative and qualitative green analytical procedure index (GAPI) method. [ABSTRACT FROM AUTHOR]