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

Salvala Srividya, Ettireddy Swetha, Ciddi Veeresham^*

University College of Pharmaceutical Sciences, Kakatiya University, Warangal, India.

DOI: 10.4236/ajac.2015.610076                

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 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.

Keywords

HPTLC, Saxagliptin, Quantitative Analysis, Stress Induced Degradation, Validation, API

Conflicts of Interest

The authors declare no conflicts of interest.

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