A Stability Indicating HPTLC Method Development and Validation for Analysis of Sitagliptin As Bulk Drug And In Formulation

[摘要] Sitagliptin chemically is (3R) -3-amino-1-[3- (trifluoromethyl)-6,8-dihydro-5h- [1,2,4] triazolo [3,4-c] pyrazin-7-yl]-4-(2,4,5-trifluorophenyl) butan-1-one (Fig. 1), an oral anti-diabetic agent that blocks Dipeptidyl peptidase-4 (DPP-4) activity. Sitagliptin increased incretin levels (GLP-1 and GIP) which inhibit glucagon release, in turn decreases blood glucose, but more significantly increases insulin secretion. The present work describes development and validation of a new simple, accurate, precise and stability indicating HPTLC method for the determination of sitagliptin in tablet dosage form. The chromatographic separation was achieved by using Toluene: Ethyl acetate: Methanol (3: 6: 1 v/v/v) as mobile phase and UV detection at 238 nm. The developed method was validated with respect to linearity, accuracy, precision, limit of detection, limit of quantitation and robustness as per ICH guidelines. The drug was subjected to stress condition of acid hydrolysis, alkali hydrolysis, photolysis, thermal degradation. Results found to be linear in concentration range of 100-500 ng/band. The developed method can be used for the quantification of bulk drug as well as in formulation.

[学科分类] 药学

[关键词] Sitagliptin;HPTLC;Degradation Studies