RP-HPLC Method Development and Validation for Determination of Metformin and Vildagliptin in Tablet Dosage Form

Author: Godge R.K., Dhanvate G.S., Shinde G.S. and Mankar S.D.

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Abstract

Analytical method development involves screening various column and eluent conditions, method optimization includes iterative testing of various separation conditions of the HPLC method and is performed to achieve the best possible resolution, speed, and reproducibility, robustness testing and method validation. This study aimed to develop fast, accurate, linear, sensitive and efficient high performance liquid chromatography [RP-HPLC] Methods for determining metformin and vildagliptin in pharmaceutical dosage forms. Chromatographic separation on a chromasil-C18 column [4.5 × 250 mm; 5 μm] with a mobile phase consisting of methanol: 0.1% orthophosphoric acid (80:20) adjusted to pH 4 with orthophosphoric acid. The flow is 0.7ml/min, detection wavelength is 206nm. The peak retention times of the chromatographic conditions, metformin and vildagliptin were 1.87 min and 2.54 min, respectively. The method has been validated according to ICH Q2 R1 guidelines. Calibration curves for metformin and vildagliptin were found to be linear over the concentration ranges of 2-30μg/ml and 1-15μg/ml/ml. The detection and assay limits for Metformin and vildagliptin were established at 0.21 μg/ml/ml and 0.65 μg/ml, 0.09 μg/ml/ml and 65 μg/ml respectively. A new sensitive and simple method of reversed-phase high performance liquid chromatography [RP-HPLC] has been developed and validated for the determination of metformin and vildagliptin. This method can be used for routine dosing of vildagliptin and metformin.

Keywords

Metformin, Method validation, Reverse phase high performance liquid chromatography, vildagliptin

Conclusion

The study presented in describes a new RP-HPLC method for estimating MTF and VGL combinations in mixtures using single mobile phases with low buffer concentrations compared to reported methods. The method provided good resolution between the two compounds with short analysis times (<10 minutes). The method has been verified to be simple, sensitive, accurate and precise. The recoveries indicated that the method was not interfered with by the excipients used in the formulation. Therefore, this method can be used for routine analysis of MTF and VGL in compound dosage forms.

References

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How to cite this article

Godge R.K., Dhanvate G.S., Shinde G.S. and Mankar S.D. (2023). RP-HPLC Method Development and Validation for Determination of Metformin and Vildagliptin in Tablet Dosage Form. Biological Forum – An International Journal, 15(3): 471-474.