Abstract
BackgroundAn accurate, precise and robust analytical method was developed for the impurity profiling in the metformin hydrochloride and teneligliptin hydrobromide hydrate tablet. The gradient was optimized for better separation of impurities by using BDS Hypersil C18 250 × 4.6 mm, 5µ column operated at 35 °C. The octane sulfonic acid and phosphate buffer with triethylamine at pH 3.0 were used as mobile phase A, and acetonitrile was used as mobile phase B. The mobile phase was pumped at 1.0 mL/min. The gradient was optimized for better resolution, and the chromatogram was monitored at 210 nm.ResultsThe % recovery of teneligliptin and metformin HCL observed was above 90% from LOQ level to 150%. The correlation coefficient r2 was 0.999 for metformin HCl, teneligliptin, melamine, cyanocobalamin, teneligliptin impurity A and 0.998 for teneligliptin impurity B. The method was found unaffected by change in method variance during the robustness study. During the stress study with acid, base, peroxide and temperature, maximum degradation was observed with peroxide indicating the sensitivity of the molecule toward oxidative stress.ConclusionsThe developed method is precise, accurate, robust and linear and hence can be routinely used for the related substance analysis of metformin hydrochloride and teneligliptin hydrobromide hydrate tablet in the quality control laboratory at manufacturing site during the commercial manufacturing.
Highlights
An accurate, precise and robust analytical method was developed for the impurity profiling in the metformin hydrochloride and teneligliptin hydrobromide hydrate tablet
We found some methods like individual impurity profiling methods of Metformin hydrochloride (MTF) and teneligliptin hydrobromide hydrate (TNG) [20,21,22,23], degradation of linagliptin in the presence of metformin HCL, impurity of glimepiride and metformin HCl [24, 25], while simultaneous estimation of omarigliptin, trelagliptin and alogliptin from rat plasma [26]
Linearity and Range During the linearity study, we found that the area under the curve for each analyte peak and impurities was linear to the concentration
Summary
Precise and robust analytical method was developed for the impurity profiling in the metformin hydrochloride and teneligliptin hydrobromide hydrate tablet. Metformin hydrochloride (MTF) MTF (Fig. 1a) is a biguanide derivative used to lower the blood glucose concentration in patients with noninsulin-dependent diabetes mellitus [1]. It is 1,1-dimethylbiguanide hydrochloride soluble in water, marginally soluble in ethanol and almost insoluble in acetone and methylene chloride [2]. TNG (Fig. 1b) is dipeptidyl peptidase-IV inhibitor (DPPIV), off white to cream colored powder [3]. The DPP-IV inhibitors are recently developed antidiabetic agents which have demonstrated promising results in modifying the glycemic control of diabetic patients with a minimum risk of hypoglycemia and weight gain [5]
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