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World Journal of Pharmaceutical
and Medical Research

An International Peer Reviewed Journal for Pharmaceutical and Medical Research and Technology
An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)
ISSN 2455-3301
IMPACT FACTOR: 4.103

ICV : 56.51

Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING ASSAY METHOD OF TICAGRELOR TABLETS BY USING RP-HPLC

Vegesna Swetha*, S. V. U. M. Prasad, Y. Akhila

ABSTRACT

A simple, precise and accurate RP-HPLC method has been developed and validated for stability indicating assay and dissolution of Ticagrelor as per ICH guidelines. An isocratic separation was achieved using a Develosil ODS UG-5 C18 (150 X 4.6mm, 5? particle size) columns with a flow rate of 1 ml/min and using a PDA detector to monitor the elute at 280 nm. The mobile phase consisted of potassium dihydrogen phosphate buffer: acetonitrile (60:40, v/v) with pH 3.0 adjusted with phosphoric acid. The retention time 5.35 ,linearity concentration range of 20-80 ?g/ml (r2 = 0.9992) with a limit of detection and quantitation of 0.05 and 0.15 ?g/ml respectively. Intraday and interday system and method precision were determined and accuracy was between 99.3-101.9 %. the RP-HPLC method was validated and showed to be specific, linear, accurate, precise and robust. Based on the results obtained from the analysis using proposed method, it can be concluded that the method has linear response in the range of 22.5-135 ?g/ml for Ticagrelor respectively. The method is validated for linearity, precision, accuracy, LOD, LOQ, as per ICH Guidelines. The result of the analysis of pharmaceutical formulation by the proposed method is highly reproducible and reliable and is in good agreement with label claim of the drugs. The additive usually present in the pharmaceutical formulations did not interfere in the analysis. So the method can be used for dissolution study. The dissolution test developed and validated for Ticagrelor tablets was considered satisfactory for routine quality control analysis and to establish in vitro-in vivo correlation.

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