Original Articles
Manisha Kotadiya and Avani Khr
Abstract
A simple, inexpensive and non-destructive strategy was applied for quantitative analysis of teneligliptine hydrobromide hydrate by using transmission Fourier Transform Infrared (FTIR) spectroscopy for routine quality control testing. For the analysis of active pharmaceutical ingredients (API), KBr pellets were prepared having known amount of standards and samples. A procedure for FTIR spectroscopy was developed and validated. The developed method was linear with concentration range of 8 – 14 mg with the adequate precision and recoveries. The intensity (absorbance) at wave numbers of 1263 cm-1 and 3454 cm-1 were selected for optimization and validation of method. Validation parameters like Linearity, LOD, LOQ, Accuracy and Precision were performed. The regression coefficient (r2) 0.992 and 0.997 were achieved for teneligliptine hydrobromide hydrate at wave numbers of 1263 cm-1 and 3454 cm-1 respectively. The above method precisely shows the ability of FTIR spectroscopy for measurement of precise quantity of API to control the quality of finished drug formulation.