STABILITY-INDICATING HPTLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF SITAGLIPTIN PHOSPHATE IN TABLET DOSAGE FORM

Ganesh S. Sarowar, Padmanabh B. Deshpande*, Yogesh R.Gandhi, Janvi J. Bhatt

ABSTRACT

The present work describes a new simple, precise and selective stability- indicating high performance thin layer chromatographic (HPTLC) method for estimation of Sitagliptin Phosphate as bulk drug and in tablet dosage form. The chromatographic development was carried out on precoated silica gel 60 F254 aluminium plates using mixture of Toluene: Methanol (8:2, v/v) as mobile phase. Densitometric evaluation of band was carried out at 265 nm. The retention factor for Sitagliptin Phosphate was found to be 0.38 ± 0.006. The drug was subjected to stress condition of hydrolysis (acid, base), oxidation, photolysis and thermal degradation. The accuracy and reliability of the proposed method was ascertained by evaluating various validation parameters like linearity (2000-12000 ng band-1.), precision (intra-day RSD 0.76-1.19 %, inter-day RSD 1.34-1.82 %), accuracy (99.54±0.58) and specificity according to ICH guidelines. The method has been successfully applied for the analysis of drug in pharmaceutical formulation. The % assay (Mean ± S.D.) was found to be 98.99 ± 1.48. The developed method can be used for checking the stability of Sitagliptin Phosphate in bulk drug and pharmaceutical dosage form.

Keywords: Sitagliptin, HPTLC, Forced degradation, Validation.