Development and validation of UV spectrophotometric method and highperformance thin layer chromatographic (HPTLC) method for estimation ofteneligliptin hydrobromide in pharmaceutical preparation.

摘要

Simple, rapid, sensitive, precise and specific UV spectrophotometric and High-performance thin layer chromatographic (HPTLC) methods for the determination of Teneligliptin Hydrobromide both in bulk drug and pharmaceutical dosage form were developed and validated. In UV spectrophotometric method, the solutions of Teneligliptin HBr were prepared in water. The standard solution of Teneligliptin HBr showed maximum absorption at wavelength 243.5 nm. The drug obeyed Beer–Lambert’s law in the concentration range of 10– 90 μg/mL with coefficient of correlation (r2) of 0.999. For HPTLC method, the method employed aluminium plates precoated with silica gel G60 F254 as the stationary phase. The solvent system consisted of toluene: chloroform: ethanol: diethyl amine in the proportion of 4:4:1:1, v/v/v/v. This solvent system was found to give compact spots for Teneligliptin HBr with Rf value 0.16 ± 0.01. Densitometric analysis of Teneligliptin HBr was carried out in the absorbance mode at 254 nm. Linear regression analysis showed good linearity (r2 =0.998) with respect to peak area in the concentration range of 100–600 ng/spot. The developed methods were validated as per the ICH guidelines. Statistical analysis proved that the methods are repeatable and specific for the estimation of the said drug. These methods can be adopted in routine assay analysis of Teneligliptin HBr in bulk or tablet dosage form.