Volume : 09, Issue : 02, February – 2022
Title:
22.ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TOLVAPTAN IN BULK AND ITS TABLET DOSAGE FORM BY UV- SPECTROPHOTOMETRY
Authors :
Bhavana Goud Ranga, Rithika Sankepally, Sneha Sollu, Venkateswara Rao Pragada, M Akiful Haque, Vasudha Bakshi, Narender Boggula*
Abstract :
Pharmaceutical analysis plays a vital role in the Quality Assurance and Quality control of bulk drugs. Validation is a documented program that provides a high degree of assurance that a facility or operation will consistently produce product meeting a predetermined specification. The main objective was to develop and validate the UV-spectrophotometric method for the estimation of tolvaptan in bulk and pharmaceutical formulations as per ICH guidelines. The initial stock solution of tolvaptan was prepared in acetonitrile. The λmax of tolvaptan was found to be 269 nm. The drug obeyed Beer-Lambert’s law in the concentration range of 20-140% of standard concentration (μg/ml) of 30 mg with coefficient of correlation (r2) was 0.999. The accuracy studies of proposed method was performed at three different levels, i.e., 50%, 100%, and 150% and recovery was found to be in the range of 100.4%. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.34 and 0.94 µg/ml respectively. The %RSD less than 2 which indicates the accuracy and precise of the method. The above method was a rapid tool for routine analysis of tolvaptan in the bulk and in the pharmaceutical dosage form. The method can be useful for the day-to-day routine analysis in the quality control departments of bulk and pharmaceutical formulations industries. So, we concluded that a simple, rapid, precise and accurate spectrophotometric method has been developed for quantitative analysis of tolvaptan API and its tablet formulation.
Key words: Tolvaptan, UV-Spectrophotometry, vasopressin receptor-2 antagonist, linearity, accuracy, validation.
Cite This Article:
Please cite this article in press Narender Boggula et al, Analytical Method Development and Validation of Tolvaptan in Bulk and Its Tablet Dosage Form By UV- Spectrophotometry., Indo Am. J. P. Sci, 2022; 09(2).
Number of Downloads : 10
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