Development of Validated Stability Indicating High Performance Thin Layer Chromatography (HPTCL) Method For Repaglinde

Abstract

A simple, specific, precise and accurate stability-indicating assay method using high performance thin-layer chromatography (HPTLC) is described for estimation of repaglinide in bulk drug and in pharmaceutical formulations. The separations were achieved on prepared TLC plates precoated with silica gel 60 F254. The mobile phase developed and optimized for bringing out the separation involves chloroform–methanol–ammonia in the ratio of 4.5:1.0:0.05 v/v/v. The densitometric scanning wavelength selected was 242 nm. The compact bands of repaglinide were obtained at RF value of 0.31 ± 0.02. The method developed was able to separate peaks of all the degradation products formed in ICHprescribed stress conditions with sufficient difference in their RF values. The developed method was validated for linearity and range, specificity, precision, accuracy and robustness, and the results were found to be within acceptance criteria. The reliability of the method was evaluated when it was applied for the estimation of repaglinide in pharmaceutical tablet formulation, and assay results gave good recovery. The developed method was also applied for content uniformity of repaglinide in tablet dosage form.