ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TOLVAPTAN IN BULK AND ITS TABLET DOSAGE FORM BY UV- SPECTROPHOTOMETRY

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 λ_max 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.