Journal of Chemical and Pharmaceutical Research (ISSN : 0975-7384)

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Original Articles: 2017 Vol: 9 Issue: 5

A Validated Stability-Indicating High Performance Thin Layer Chromatographic Method for the Analysis of Saxagliptin in Bulk Drug and Tablet Formulation


The objective of the present research work is developing a simple, precise, and accurate stability-indicating normal-phase HPTLC method for estimation of Saxagliptine in the bulk drug and tablet formulation. Chromatography was performed on the plates precoated with silica gel 60F254 using 1% methanolic ammonium acetate: toluene 5:5 (v/v) as a mobile phase. Densitometric quantification was performed at 215 nm by reflectance scanning. The retardation factor of Saxagliptine was 0.48 ± 0.02. Validation of the method in accordance with ICH guidelines yielded good results for range, linearity, precision, accuracy, specificity and robustness. The data of linear regression analysis indicated a good linear relationship over the range of 300– 1100 ng/band concentrations with correlation coefficient 0.997. The limits of detection and quantitation were found to be 0.25 and 0.77 resp. Results from analysis of a commercial tablet formulation was 99.12 ± 1.58%. The method precision for the determination of assay was below 2.0 %RSD. The percentage recoveries of active pharmaceutical ingredient (API) from dosage forms ranged from 99.97% to 101.11%. Stress testing of Saxagliptin 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 which enabled separation and detection of degradation products from acidic, basic, neutral and oxidation stress. No degradation products were obtained after photo and dry heat stress condition.