Abstract
APPLICATION OF VALIDATED STABILITY INDICATING HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC METHOD FOR DETERMINATION OF LINAGLIPTIN IN TABLET DOSAGE FORM

Sumit Soundale, Padmanabh B. Deshpande* and Akshay Kale

ABSTRACT

Linagliptin is an inhibitor of dipeptidylpeptidase-4 (DPP-4) enzyme that degrades the incretin hormones glucagon-like peptide-1 and glucose-dependent insulin tropic polypeptide and is used to lower the increased blood sugar level. High performance thin layer chromatography method has been used for chromatographic separation of Linagliptin and was carried out by using precoated with silica gel 60 F254 aluminium plates as stationary phase and mixture consisting of Toluene: Methanol in the ratio of (8: 2, v/v) as optimum mobile phase. Densitometric detection of separated spot was carried out at 294 nm. The developed method has been successfully applied for the estimation of Linagliptin in tablet dosage form. Linagliptin was subjected to stress condition of hydrolysis (acid, base), oxidation, photolysis and thermal degradation and analyzed under optimized chromatographic conditions. Linagliptin was satisfactorily resolved with retention factor value of 0.38 ± 0.02. Linear response was observed in the concentration range of 100-600 ng band-1. The % assay (Mean ± S.D.) was found to be 100.61 ± 1.52. Linagliptin was found susceptible to hydrolysis, oxidative and thermal stress conditions. The developed method can be used for the analysis of Linagliptin without any interference from the excipients and can be successfully used to estimate the amount of drug in the formulations by easily available low cost materials.

Keywords: Linagliptin; HPTLC; Forced degradation; Tablet dosage form.


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