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THE PHARMA REVIEW (NOVEMBER DECEMBER 2012)

Stability Indicating RP-HPLC Method for Estimation of Ticlopidine in Pharmaceutical Preparations

R. B. Kakde, A. G. Barsagade, K. G. Gadapayale, G. R. Kalyankar & R. P. Chilbule

Introduction:
 
A simple, precise, and accurate stability-indicating reversed phase HPLC method has been established for analysis of ticlopidine in the bulk drug and dosage form. Chromatography was performed on reversed phase RP-C18 column at flow rate 1 ml/min and detection was carried out at wavelength 235 nm. The mobile phase containing phosphate buffer which is mixture of 50mM potassium dihydrogen phosphate with 30mM triethylamine (pH 3, adjusted with orthophosphoric acid) and acetonitrile in the ratio 30:70 v/v was found to be most satisfactory as it gave good resolution of drug and degradation products with reasonably symmetrical sharp peaks. The retention time under optimised condition was found to be 4.34 0.30 min. The total run time of chromatogram was about 7 min. 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 7 to 13 g; the correlation coefficient was 0.9997. The limit of detection was 7.1296 g. Results of commercial tablet formulations were found to be 99.49 0.3053%. Recovery of the drug was found to be 100.54 1.3707%. The retention time of degradants in bulk drug were 3.34 (Alkaline and Neutral stress), 1.74 and 2.18 (30% H2O2), 1.65 (Sunlight) and 3.35 (Dry heat) with baseline separation. In case of formulation, alkaline and neutral stressed sample chromatogram shows extra degradation products apart from degradation product generated in bulk drug due to drug–excipient interaction. All degradation products as a result of stress condition does not interfere with the assay of ticlopidine.

 

 

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