Stability-Indicating HPTLC Method for Analysis of Ticlopidine in Pharmaceutical Preparations

A simple, precise, and accurate stability-indicating normal-phase HPTLC method has been established for analysis of ticlopidine in the bulk drug and dosage form. Chromatography was performed on silica gel 60F(254) with toluene-methanol 98:2 (v/v) as mobile phase. Densitometric quantification was performed at 240 nm by reflectance scanning. The R(F) of ticlopidine was 0.60 +/- 0.03. Validation of the method in accordance with ICH guidelines yielded good results for range, linearity, precision, accuracy, specificity, robustness and ruggedness. Response was a linear function of concentration of ticlopidine over the range 800-1500 ng; the correlation coefficient was 0.999. The limit of detection was 35.38 and 0.15 ng per band by peak height and peak area respectively. Results from analysis of a commercial tablet formulation were 99.00 +/- 0.607% by peak height and 99.33 +/- 0.995% by peak area. Recovery was 98.49 +/- 0.649% and 99.07 +/- 0.734% by peak height and peak area, respectively. The conditions used also enabled separation and detection of degradation products from oxidative, dry heat, and photolytic stress. All degradation products were of identical RF but their spectra were different, indicating different compounds were produced. No degradation products were obtained after acid, alkaline, and neutral hydrolysis.