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Pharmaceutics
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AN IMPROVED AND VALIDATED RP HPLC METHOD DEVELOPMENT FOR THE QUANTITATIVE ESTIMATION OF TICAGRELOR


Abstract

Author(s): Amgoth Krishnamanjari Pawar, Putrevu Satya Mounika, Sindhe Divyasree, Kammakattu Sandeep Kumar Reddy, Vaddeswaram Ashok Babu

A simple, precise and accurate reverse phase high performance liquid chromatography (RP- HPLC) method was developed
and validated for the determination of ticagrelor using Unisol C18 (150 mm × 4.6 mm, 3 μ) with a mobile phase consisting of
700 mL of HPLC grade methanol and 300 mL of triethanolamine buffer of pH 4.5. The detection was carried out at 240 nm
and retention time of ticagrelor was found to be 3.247 min. Linearity was observed from 10 to 120 μg/mL (coefficient of
determination R2 was 0.998) with equation, y = 3878x + 6460. The method was statistically validated for accuracy, precision,
linearity, ruggedness, robustness, solution stability, selectivity as per ICH guidelines. The results obtained in the study were
within the limits of ICH guidelines and hence this method can also be used for the determination of ticagrelor in
pharmaceutical dosage forms.

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Citations : 440

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