Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR ESTIMATION OF ALOGLIPTIN BENZOATE

Dalavi Nilam B.*, Badadhe Sandip and Bhasme P. S.

ABSTRACT

An approach for the stress degradation was successfully applied for the development of stability indicating HPTLC method for the determination of Alogliptin Benzoate on the plates precoated with silica gel 60 F254. The chromatographic separation was achieved by using Benzene: Ethyl acetate: Methanol (6.5: 2.5: 5.5, v/v/v) as mobile phase and UV detection at 254 nm. Stress testing of Alogliptin Benzoate was carried out according to the International Conference of Harmonization (ICH) guideline Q1A (R2). The drug was subjected to acid, base, neutral hydrolysis, oxidation, thermal degradation and photolysis. The system showed a peak for Alogliptin Benzoate at Rf value of 0.25 ± 0.0052. The method was successfully validated according to ICH guidelines Q2 (R1). The data of linear regression analysis indicated a good linear relationship over the range of 200–1200 ng/band concentrations with correlation coefficient value greater than 0.999. The accuracy of the method was established based on the recovery studies. The LOD and LOQ were 135.33 ng/band and 410.0 ng/ band respectively. Under various tested stressed conditions, Losartan Potassium showed considerable degradation under alkali, acidic, oxidative and neutral hydrolytic condition.

Keywords: Alogliptin Benzoate, High Performance Thin Layer Chromatography, Stability.