Novel and ecofriendly UV-Spectrophotometry methods for estimation of Tolvaptan using hydrotropic agent

Abstract

The aim of present investigation is to establish simple and economical UV- Spectrophotometric methods for estimation of Tolvaptan using Zero order UV-Spectrophotometric absorbance method and Zero Order- Area under curve (AUC) method with the application of hydrotropic solubilization phenomenon. Tolvaptan is non-peptide vasopressin V2 receptor antagonist. It is completely insoluble in water. Hydrotropic agent, sodium lauryl Sulfate (SLS) 5% w/v was used to enhance the solubility of Tolvaptan. Maximum absorption for Tolvaptan was found to be at 269 nm. The methods are based upon measurement of absorbance at 269 nm and integration of area under curve for analysis of Tolvaptan in the wavelength range of 263.2-282.2 nm. The drug followed linearity in the concentration range of 3 - 18 µg/mL with correlation coefficient value r2> 0.99 for both methods. The proposed methods were validated for accuracy, precision, repeatability and ruggedness, as per ICH guidelines. The proposed methods were applied for qualitative and quantitative estimation of Tolvaptan in pharmaceutical formulation and results were found in good agreement with the label claimed. Developed methods can be used for routine analysis of Tolvaptan in bulk and tablets. Keywords: Sodium Lauryl Sulphate, Tolvaptan, UV- Spectrophotometry - Area under Curve, UV-Spectrophotometry, Hydrotropy .