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Abstract

Development and Validation of High-Performance Thin-Layer Chromatography Method for Estimation of Teneligliptin in Bulk and In Pharmaceutical Formulation

Author(s): Prafulla M Patil, Pritam S Jain, Sanjay J Surana and Swati D Yeole

A high-performance thin layer chromatographic method for determination of Teneligliptin was developed and validation as per ICH guidelines. HPTLC separation was performed on aluminum plates precoated with silica gel 60F254 and Methanol: Toluene: Triethylamine (1:3:1% v/v) as optimized mobile phase at detection wavelength of 245 nm. The retardation factor (Rf) value for Teneligliptin were 0.63 respectively. Accuracy for the marketed formulation teneza was found to be 98.31-100.51%.The percent relative standard deviation for repeatability and intermediate precision studies was found to be < 2%. The propose development HPTLC method can be applied for identification and quantitative determination of Teneligliptin


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