Abstract
A simple, accurate, precise and rapid stability indicating reverse phase High performance chromatography method was used for estimation of Sitagliptin/metformin HCl ER tablets in bulk and fixed-dose combination solid oral dosage form. The proposed analytical method has been validated for specificity, Linearity, Accuracy, Precision and Robustness. The chromatography was achieved in a Avantor, ACE C18 (Length 150 x Diameter 4.6mm Particle size 5µm) column with gradient flow. The optimal chromatographic condition consisted of mobile phase pH 3.5 at a flow rate of 1.2 mL/min, with a column temperature of 35°C, run time 17 minutes and detector wavelength of 210 nm (Sitagliptin& Propyl gallate and Metformin HCl).
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