VALIDATED STABILITY INDICATING HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC METHOD FOR REPAGLINIDE API

A simple, precise and accurate stability-indicating high performance thin layer chromatographic method for estimation of repaglinide in bulk drug and in tablet formulation has been developed and validated. The stationary phase used was HPTLC plates precoated with silica gel 60F254 using the mobile phase of chloroform: methanol: ammonia (4.5:1.0:0.05 V/V/V). Densitometric analysis was performed in absorbance mode at 242 nm. The method showed compact bands of drug at RF value of 0.31 ± 0.02. Linear Regression analysis of calibration data showed good linear relationship with r2= 0.9981 in concentration range of 500 - 3000 ng/band. Drug was subjected to ICH-prescribed stress conditions such as acid, base, peroxide, thermal and photolytic degradation and method was found able to separate the peaks for all degradation products from analyte peak. Validation of the developed method was carried out for its specificity, linearity, range, precision, accuracy and robustness. The method was further applied for repaglinide estimation in pharmaceutical tablet formulation and it was found to be reliable. The method was also used successfully to carry out content uniformity test of repaglinide in tablet dosage form.