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Asian Journal of Pharmaceutical Research
Year : 2019, Volume : 9, Issue : 3
First page : ( 141) Last page : ( 146)
Print ISSN : 2231-5683. Online ISSN : 2231-5691.
Article DOI : 10.5958/2231-5691.2019.00022.4

Analytical Method Development and Validation of Ticagrelor from Bulk and Formulation

Gupta Anand*, Jadhav Vaishali, Jain Ashish

Shri. D. D. Vispute College of Pharmacy & Research Center, New Panvel

*Corresponding Author E-mail: anandgpt15@gmail.com

Online published on 31 December, 2019.

Abstract

Ticagrelor is a Platelet Aggregation Inhibitor which is white to off-white, highly crystalline and non-hygroscopic powder, having High Solubility and Low Permeability. A Simple, Rapid, Selective, Precise and Accurate UV and HPLC Method have been developed for the Estimation of Ticagrelor in bulk drugs and its Tablet dosage form. The max was found to be λmax 255 nm. As per the solution stability experiments, this drug was stable in the solvent composition of ACN: Methanol (85: 15 v/v) and hence used as a diluent for sample preparation. The developed method was optimized to get reproducible results with minimum run time. The Stationary Phase was C18 (250 x 4.6 mm i.d., 5μ) Mobile Phase was ACN: Methanol (85: 15 v/v), Flow rate 1.0 ml/min, Injection volume 10 μl, PDA detection at λmax 255nm and Run time 7 min. It provides a linear response over the Conc. Range of 5–25 μg/ml with Correlation Co-efficient of 0.999 and LOD and LOQ was found to be 0.20 μg/ml and 0.61 μg/ml respectively. %Recovery was found to be 99.06, 99.77, and 100.99% for the levels of 80, 100, and 120% respectively. Both the Method was found to be Robust with better accuracy and Precision having % RSD value less than 2.

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Keywords

Ticagrelor, Validation, Method Development, Assay Method.

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