Volume :
2
Issue :
3
Abstract :
A simple, precise, selective and accurate isocratic reversed phase high performance liquid chromatographic method was developed for the simultaneous determination of Sitagliptin phosphate and Metformin hydrochloride in the tablet dosage form. A chromatographic separation was achieved on reverse phase phenomenex Luna C18 column (250 ×4.6 mm, 5µ). The mobile phase consists of mixture of 0.1% v/v triethylamine and acetonitrile (70:30 v/v). The pH of 0.1% v/v triethylamine was adjusted to pH 3.5 using 0.1%v/v orthophosphoric acid. The flow rate was 1ml/min and the effluents were monitored at the detection wavelength of 254nm.The retention times of Metformin and Sitagliptin were found to be 2.13 and 4.08 min respectively. The method was validated for the linearity, accuracy, precision, robustness, system suitability as per ICH guidelines. Sitagliptin phosphate and Metformin hydrochloride were found to be linear in the range of 10-100 and 5-50µg/ml with the recoveries of 99.21% and 101.69%. The method was also applied for the determination of Metformin and Sitagliptin in the presence of their degradation products formed under variety of stress conditions.