TITLE:
Development and Validation of a High Performance Thin Layer Chromatographic Method for Quantitative Analysis of Saxagliptin
AUTHORS:
Salvala Srividya, Ettireddy Swetha, Ciddi Veeresham
KEYWORDS:
HPTLC, Saxagliptin, Quantitative Analysis, Stress Induced Degradation, Validation, API
JOURNAL NAME:
American Journal of Analytical Chemistry,
Vol.6 No.10,
September
16,
2015
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 F254 (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 Rf 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.