Development and Validation of a High Performance Thin Layer Chromatographic Method for Quantitative Analysis of Saxagliptin

Abstract

A simple, specific, accurate and precise high performance thin layer chromatographic method (HPTLC) was developed for the quantitative analysis of Saxagliptin in active pharmaceutical ingredients (APIs) and pharmaceutical dosage forms. The method was achieved using silica gel aluminum plate 60 F 254 (10 × 10 cm) as stationary phase and Methanol:Chloroform (6:4 v/v) as mobile phase. The developed plate was scanned densitometrically using UV 222 nm wavelength. The R f value of Saxagliptin was found to be 0.50 ± 0.02. The developed method was validated according to ICH guidelines. Limit of detection (LOD) and limit of quantification (LOQ) of Saxagliptin by this method were found as 7.96 ng/spot and 26.54 ng/spot, respectively. The method was found to be sensitive, specific, linear, accurate, precise and robust for the quantitative analysis of Saxagliptin in both APIs and marketed tablet formulation.

Pharmacology and Analytical Chemistry Profile of Dapagliflozin, Empagliflozin and Saxagliptin

“…HPTLC was developed for the quantitative analysis of SXG in active pharmaceutical ingredients (APIs) and pharmaceutical dosage forms. The method was achieved using silica gel aluminum plate 60 F254 (10 × 10 cm) as stationary phase and methanol: chloroform (6:4 v/v) as mobile phase [53]. HPTLC method for the simultaneous determination of metformin, SXG and DGF in pharmaceuticals.…”