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ISSN 2063-5346
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BIO-ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ARMODAFINIL IN RABBIT PLASMA USING REVERSE PHASE -HPLC

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Swetha Vegesna, Chennu MM Prasada Rao
» doi: 10.31838/ecb/2023.12.s3.389

Abstract

A simple, Accurate, precise method was developed for the simultaneous estimation of Armodafinil in human plasma was developed and validated. By using Protein Precipitation, the sample preparation was prepared. Chromatogram was run through Agilent C18 (150x 4.6 mm, 5) Mobile phase containing Buffer KH2PO4: Methanol taken in the ratio 55:45 was pumped through column at a flow rate of 0.2ml/min. Buffer used Potassium Phosphate Buffer in this method was buffer. For the separation of Armodafinil Internal Standard [IS] used is Dolutegravir. The Temperature was maintained at 30°C. Optimized wavelength selected was 260.0nm. Retention time of Armodafinil and Internal Standard were found to be 2.728 min and 3.159 min. The standard curve was linear (R2 >0.995) over the concentration range of 0.065-2.6 ng/ml. According to ICH guidelines, each analytical validation parameter was determined. As accuracy, precision, recovery, and other validation parameters were all within the guidelines' constraints, the bioanalytical technique created approach was selective, robust, and reliable. Without any interference from plasma, the peaks generated for the target substance and the internal standard were adequately separated from one another and had a sufficient tailing factor. Therapeutic drug monitoring (TDM), bioequivalence research, pharmacokinetics studies, toxicology, and biological investigations might all greatly benefit from the technique.

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