DEVELOPMENT AND VALIDATION OF A NEW STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ASPIRIN AND TICLOPIDINE

Y. Himaja, G. Josephine, M. Aparna, Sowjanya G., *P. Sridevi, Vinutha K., M. Bhagavan Raju

ABSTRACT

A new stability indicating RP HPLC method has been developed and validated for simultaneous estimation of Aspirin and Ticlopidine in bulk and dosage forms. The method involves separation on Xterra C18 column (250mm x 4.6mm x5μm particle size). The optimized mobile phase consists of 0.1% OPA (pH 2.8) and Methanol (45:55v/v) with a flow rate of 1ml/min and UV detection at 229mn. Retention time was 2.78 min (Aspirin), 3.71 min (Ticlopidine). Linearity range was 20-100 ug/ml (Aspirin), 60-300 ug/ml (Ticlopidine). Accuracy was in the range of 96.92-100.35% for both drugs. Precision was 0.8% and 0.5% for Aspirin and Ticlopidine. LOD and LOQ are 0.42ug/ml and 1.38 ug/ml for Aspirin, 0.27ug/ml and 0.89ug/ml for Ticlopidine. The method developed is more sensitive, accurate and precise than the methods reported earlier. Retention time and run time were also less and hence the method is economical. When applied for tablet assay, drug content was within 98.55-101.4 % of labelled content. Forced degradation studies indicated the suitability of the method for stability studies.

Keywords: Aspirin and Ticlopidine, RP-HPLC Method, Simultaneous estimation, Validation, Forced degradation studies.