Environment safe Method development and Validation of Dolutegravir in Bulk and Tablet dosage form by UV-Visible spectroscopy

Abstract

To develop an environment-safe aqueous solubility enhancement method of poorly water-soluble drugs is the need of the pharmaceutical field. Because when organic solvents were used for solubility enhancement, there are many disadvantages like carcinogenicity, environment pollutant, flammable, toxicity, and cost. The hydrotropic method has been used to enhance the aqueous solubility of poorly water-soluble drugs. Dolutegravir is slightly soluble in water. To enhance aqueous solubility various hydrotropes were used and optimized the concentration of each hydrotrope. From these hydrotropes, a mixture of 10% sodium tricitrate and 10% sodium benzoate was selected because Dolutegravir was completely soluble in a mixed hydrotropic solution. Method development and analytical validation were performed. The maximum wavelength of Dolutegravir in the hydrotropic mixture was found a 268nm, and the linearity curve in the range of 5-25µg/ml. A regression coefficient was found to be 0.999. Percent label claim, accuracy (% RSD) were found 99.58%, 0.13(80%), 0.11(100%), 0.13(120%), respectively. The LOD for Dolutegravir was determined to be 0.037μg/ mL, and LOQ was found to be 0.11μg/mL.