Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ZERO-ORDER APPROACHES FOR TOLVAPTAN ESTIMATION IN BULK AND TABLET DOSAGE FORM

Dr. Sowmya H. G., Bhagyashree K. C.*, Dr. Naveen Kumar G. S.

Abstract

A novel, accurate, and efficient zero order derivative UV spectroscopic method has been developed and validated for the quantification of Tolvaptan in both bulk drug and pharmaceutical dosage forms. Tolvaptan exhibits maximum absorbance at 267 nm in Acetonitrile and its concentration follows Beer's Law within the range of 3-18 μg/mL. The method showed strong linearity, with a correlation coefficient (r2) of 0.9967, indicating high consistency and reliability across the studied range. Recovery rates were observed between 98.5%, 103.1% and 98.7%, while the limits of detection (LOD) and quantification (LOQ) were found to be 0.066 μg/mL and 0.202 μg/mL respectively. The method also demonstrated excellent precision, with relative standard deviation (%RSD) values below 2%. All validation parameters-linearity, accuracy, precision, robustness, ruggedness, LOD, and LOQ-were assessed according to ICH guidelines. This validated spectroscopic approach proves to be a dependable and reproducible method for routine analysis of Tolvaptan in various pharmaceutical preparations.

Keywords: Tolvaptan Quantification, Validation, RP-HPLC, HPTLC, Anti-diuretics.