Abstract

SPECTROSCOPIC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF DAPAGLIFLOZIN USING HYDROTROPHIC PHENOMENONA

Ayush Chouhan*, Shabnam Khan, Ramakant Sharma, Jeevan Patel, Dr. Rakesh Patel

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Abstract

The aim of the present study was to assess the feasibility of hydrotropes (Urea, N, N Dimethyl urea, Sodium benzoate, Sodium Acetate) for the development of an ecofriendly, operator-safe and costeffective spectroscopic method and its validation for estimation of Dapagliflozin from pharmaceutical formulation. Enhancement of solubility was more than 50 and 70 % for DAPA respectively in mixed hydrotropic solution. The enhancement of solubility of DAPA in water was due to hydrotrophy phenomenon. Stability of both drugs were observed by dissolving DAPA in Sodium acetate:Urea (2M:8M) solution used as solvent. Solution of DAPA was prepared in the conc. of 10μg/ml and scanned under time scan for 30 min. Standard stock solutions and working solutions were made using serial dilution methods DAPA's peak absorbance was noted at 225.0 nm. Linearity of both drugs was established by response ratios of drugs. Recovery studies evaluated the suggested approaches' accuracy at three distinct levels, i.e. 80%, 100%, and 120%. Precision of the methods was studie/ at three level as at repeatability, intermediate precision (Day to Day and analyst to analyst) and reproducibility. Repeatability was performed by analyzing same concentration of drugs for five times. The method's specificity was evaluated in order to conclusively determine if the analyte included any components that may be anticipated to be present, such as contaminants, degradation products, and matrix components. It was determined that the suggested approach is safe, innovative, novel, straightforward, accurate, free from pollution, exact, and it can be used effectively in the regular analysis for dapagliflozin. The offered approaches entirely achieve the goal of this study work due to their simplicity, speed, repeatability, and economy.

Keywords: Validation, estimation, Dapaglifloxin, Hydrotrophy.