Abstract
Three new UV spectrophotometric methods namely simultaneous equation, absorbance ratio and first derivative (zero crossing) spectroscopic methods were developed and validated for simultaneous estimation of teneligliptin hydrobromide hydrate and metformin hydrochloride in tablet formulation which were simple, sensitive, precise and accurate. In simultaneous equation method, absorbance was measured at 237 and 246 nm for both the drugs. Teneligliptin hydrobromide hydrate and metformin hydrochloride was estimated using 237 and 247.5 nm in absorbance ratio method. First derivative (zero crossing) method was based on the transformation of UV spectra in to first derivative spectra followed by measurement of first derivative signal at 237 and 246 nm for teneligliptin hydrobromide hydrate and metformin hydrochloride, respectively using 2 nm as wavelength interval (Δλ) and 1 as scaling factor. Developed methods were validated according to ICH guidelines including parameters viz., specificity, linearity and range, precision, accuracy, limit of detection and quantification. All the three methods showed linear response in the concentration range of 1-20 µg/ml for both the drugs. Results of method validation parameters follows ICH guideline acceptable limits. Based on the assay results obtained, methods were compared using one-way ANOVA followed by Bonferroni multiple comparison tests (95% confidence level) using computer based fitting program (Prism, Graphpad version 5, Graphpad Software Inc). Outcome of the statistical analysis proved that there was no considerable dissimilarity between all the developed methods. Methods were found to be simple, fast, highly sensitive, cost effective and hence can be useful for simultaneous estimation of teneligliptin hydrobromide hydrate and metformin hydrochloride in commercial tablet formulation for routine quality control analysis.
Highlights
Teneligliptin hydrobromide hydrate (TEN) is chemically described as {(2S,4S)-4-[4-(3-methyl-1phenyl-1Hpyrazol-5-yl) piperazin-1-yl] pyrrolidin-2-yl} (1,3-thiazolidin-3yl) methanone hemipentahydrobromide hydrate is a dipeptidyl peptidase inhibitor
First derivative method was based on the transformation of UV spectra in to first derivative spectra followed by measurement of first derivative signal at 237 and 246 nm for teneligliptin hydrobromide hydrate and metformin hydrochloride, respectively using 2 nm as wavelength interval (Δλ) and 1 as scaling factor
Developed methods were validated according to ICH guidelines including parameters viz., specificity, linearity and range, precision, accuracy, limit of detection and quantification
Summary
Teneligliptin hydrobromide hydrate (TEN) is chemically described as {(2S,4S)-4-[4-(3-methyl-1phenyl-1Hpyrazol-5-yl) piperazin-1-yl] pyrrolidin-2-yl} (1,3-thiazolidin-3yl) methanone hemipentahydrobromide hydrate is a dipeptidyl peptidase inhibitor. TEN slows the inactivation of incretin hormones, thereby increasing bloodstream concentrations and reducing fasting and postprandial glucose concentrations in a glucose-dependant manner in patients with type 2 diabetes mellitus. Metformin hydrochloride (MET) is 1,1-dimethylbiguanide hydrochloride, a biguanide antidiabetic. It is given orally in the treatment of type 2 diabetes mellitus and is the drug of choice in overweight patients. They do not stimulate insulin release but require that some insulin be present in order to exert their antidiabetic effect. Possible mechanism of action includes the delay in the absorption of glucose from the GIT and increase in insulin sensitivity and glucose uptake in to cells and inhibition of hepatic gluconeogenesis (Indian Pharmacopoeia, 2007; The Merck Index, 2001; Martindale, 2009; Sen et al, 2015)
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
