Author(s): S Ashutosh Kumar, Manidipa Debnath, J V L N Seshagiri Rao
A new simple, accurate, precise, reproducible stabi lity indicating Reverse Phase-High Performance Liqu id Chromatography method was developed for the simult aneous estimation of Metformin and Sitagliptin in b ulk as well as in pharmaceutical dosage form by using Symm etry C18 column (4.6 x 150mm, 3.5 μ m, Make: XTerra) in isocratic mode. The mobile phase was prepared by us ing Potassium Dihydrogen Phosphate and Acetonitrile in different ratio at different pH. Several trials wer e performed and it was found that the ratio 0f 65:3 5 of Potassium Dihydrogen Phosphate (with pH 5.8 which was adjuste d by using Sodium Hydroxide) and Acetonitrile respe ctively shown a good peak. The detection was carried out at 254 nm. The method was linear over the concentrati on range for Metformin 100-300ppm and Sitagliptin 10-30ppm. The % recoveries of Metformin and Sitagliptin were found to be 98.8 to 100.7% and 99.1 to 100.6% respectively. The LOD for the drug Metformin was found to be 0.06 μ g/ml, LOQ for the Drug Metformin was found to be 0.2 μ g/mL & the LOD for the drug Sitagliptin was found t o be 0.1 μ g/mL, LOQ for the drug Sitagliptin was found to be 0.4 μ g/mL. The drug content formulations were quantified by using the proposed analytical method. The proposed method can be successfully applied in the quality c ontrol of bulk and pharmaceutical dosage forms. The method wa s also applied for the determination of Metformin & Sitagliptin in the presence of their degradation pr oducts formed under variety of stress conditions. T he method was applied for the determination of Metformin & Sitagl iptin in the presence of their degradation products formed under the variety of stress conditions. The validation of method was carried out utilizing International Con ference on Harmonization (ICH) guidelines. The described High Performance Liquid Chromatography method was successfully employed for the analysis of pharmaceu tical formulations containing combined dosage form.