A VALIDATED BIOANALYTICAL METHOD FOR QUANTIFICATION OF TOLVAPTAN BY RPHPLC-UV
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Keywords
Bioanalytical Method Development and Validation, Tolvaptan, Mobile Phase, HPLC, Column selection
Abstract
Tolvaptan is a critical therapeutic agent for the treatment of various medical conditions, including hyponatremia and polycystic kidney disease. Developing a sensitive and reliable bioanalytical method for the quantification of Tolvaptan is essential to ensure its quality and efficacy in pharmaceutical formulations. In this study, a novel bioanalytical method for the estimation of Tolvaptan was developed and validated. The method was carried out with an Agilent HPLC with a UV detector. Column Agilent Eclipse XDB C-8 column was used at a flow rate of 1.0 mL/min. Detection was carried out at 253nm. The mobile phase consisting of a mixture of Methanol: 0.05 M Phosphate buffer (pH 5) (70:30 v/v) respectively. Developed method demonstrated excellent linearity over a wide concentration range (0.1 to 5µg/ml) and exhibited precision and accuracy within acceptable limits. The lower limit of quantification (0.5μg/ml) was, indicating the method's sensitivity. This validation will serve as a crucial foundation for its application in pivotal and crucial studies related to bioavailability, bioequivalence, pharmacokinetics, and toxic kinetics.
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Kumudini Rahul Pawar
Research Scholar, SJJTU University, Jhunjhunu, Rajasthan, India
Sanjay K Bais
Research Supervisor, SJJTU University, Jhunjhunu, Rajasthan, India