Articles Accepted

INTENDED STABILITY INDICATING RP-HPLC METHOD FOR THE SEPARATION AND QUANTIFICATION OF RELATED SUBSTANCES OF TICLOPIDINE IN BULK AND PHARMACEUTICAL FORMULATIONS
by Ms. sai prudhvi, 27 Dec 2018

A simple, specific, accurate and stable reverse phase liquid chromatographic method was developed for the simultaneous determination of Ticlopidine and its related impurities A and B in bulk drug and tablet dosage forms. The analysis has been performed by using XTerra C18 column (250mm×4.6mm; 5µ id) and mobile phase containing of methanol and pH 6.8 phosphate buffer at in the ratio of 80:20 (v/v). The detection was carried out at 228 nm with a flow rate of 1.0 mL/min. The retention times were found to be 8.9, 5.98 and 4.62 min for Ticlopidine, impurity A and B respectively. The method was validated according to ICH guidelines. The method was validated for specificity, precision, linearity, accuracy and robustness. The linearity range of 50-200 µg/mL for Ticlopidine and 0.5-2.0 µg/mL for impurity A and B. The recoveries of Ticlopidine and impurities were found to be within the range of 98-102 and the % RSD in each spiked level was found to be less than 2. The stress degradation studies confirm that the method was effectively separate the degradation products and impurities formed in the stress studies and hence the method was found to be stability indicating method. The method can effectively quantify the standard drug Ticlopidine and its impurities A and B in bulk drug and pharmaceutical formulations.

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