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Simultaneous Estimation of Metformin HCl and Sitagliptin Phosphate in API and Tablet Dosage by HPLC Method.

Pragati Sinha, Dharam Pal Pathak and Jai Prakash

A simple, accurate, precise and rapid reversed phase high performance liquid chromatography (RP-HPLC) method had been developed and subsequently validated for the simultaneous estimation of metformin HCl and sitagliptin phosphate in bulk & tablet dosage form. The proposed method was based on the separation of the two drugs in reversed phase mode using C18 (4.6 × 250 mm, [5 μ particle size]) analytical column. The optimized mobile phase consisted of phosphate buffer (pH adjusted to 3.11 using o-phosphoric acid): Acetonitrile in the ratio of 850:150. Flow rate was kept at 1 mL/min. The simultaneous estimation was carried out at detection wavelength of 206 nm using variable wavelength detector. Both drugs metformin HCl and sitagliptin phosphate were resolved and retained at 10 minutes. This method was statistically validated as per ICH guideline for analytical method validation.