Articles Accepted

A New Forced Indicating UPLC-DAD Method Development and Validation for the Estimation of Apalutamide in bulk and its Pharmaceutical dosage form
by Mr. Chinababu dara, 22 Mar 2019

A new analytical method was developed for the estimation of apalutamide in bulk and its pharmaceutical formulation. The sensitive, precised and accurate method was developed by using waters acquity UPLC system equipped with quaternary gradient pump. The column was used waters C18 50X 2.1 mm X 1.7 µm and mobile phase was 0.2% OPA buffer in water: acetonitrile in the ratio of 25:75 v/v and buffer pH was maintained at 4.5. The flow rate of mobile phase was 0.5 ml/min and detected at 272 nm by using PDA detector. The method was performed at ambient temperature. The retention time of the apalutamide was 1.27 min. The % RSD value in precision was >2%. The accuracy of the method was found to be between 99.54% -100.01%. The limit of detection and limit of quantification values were found to be 0.57µg/ml and 1.89µg/ml respectively. The linearity concentration range was found to be 11.25 - 67.5µg/ml it shows wider linearity concentration range. The method was showed ability towards different stress conditions of acidity, alkalinity, peroxide, UV and thermal condition. No one method was reported on this drug by using UPLC till date.

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November 2020
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