Development of stability indicating RP- HPLC method for simultaneous estimation of metformin hydrochloride and sitagliptin phosphate monohydrate in bulk as well as in pharmaceutical formulation

A new simple, accurate, precise, reproducible stability indicating Reverse Phase-High Performance Liquid Chromatography method was developed for the simultaneous estimation of Metformin and Sitagliptin in bulk as well as in pharmaceutical dosage form by using Symmetry C18 column (4.6 x 150mm, 3.5mm, Make: XTerra) in isocratic mode. The mobile phase was prepared by using Potassium Dihydrogen Phosphate and Acetonitrile in different ratio at different pH. Several trials were performed and it was found that the ratio 0f 65:35 of Potassium Dihydrogen Phosphate (with pH 5.8 which was adjusted by using Sodium Hydroxide) and Acetonitrile respectively shown a good peak. The detection was carried out at 254 nm. The method was linear over the concentration 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 0.06μg/ml, LOQ for the Drug Metformin was found to be 0.2μg/mL & the LOD for the drug Sitagliptin was found to be 0.1μg/mL, LOQ for the drug Sitagliptin was found to be 0.4μg/mL. The drug content formulations were quantified by using the proposed analytical method. The proposed method can be successfully applied in the quality control of bulk and pharmaceutical dosage forms. The method was also applied for the determination of Metformin & Sitagliptin in the presence of their degradation products formed under variety of stress conditions. The method was applied for the determination of Metformin & Sitagliptin in the presence of their degradation products formed under the variety of stress conditions. The validation of method was carried out utilizing International Conference on Harmonization (ICH) guidelines. The described High Performance Liquid Chromatography method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form.
Author(s): S. Ashutosh Kumar, Manidipa Debnath and J. V. L. N. Seshagiri Rao

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