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Abstract

APPROACH FOR SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION OF POORLY WATER SOLUBLE DRUGS CEFIXIME AND DULOXETINE BY HYDROTROPIC SOLUBILIZATION TECHNIQUE

Rajendran Vijayalakshmi*, Vadapalli S Harsha Naveena, Kota Rajashekar and Magharla Dasaratha Dhanaraju

ABSTRACT

Quantitative estimation of poorly water soluble drugs require expensive, volatile and poisonous organic solvents. In the present study hydrotropic solubilisation technique has been employed to solubilise poorly water soluble drugs, cefixime and duloxetine for their spectrophotometric analysis. The method was developed expending 20 %, w/v Sodium citrate as hydrotropic agent. The investigation proved that there is more than eight fold aqueous solubility of the drugs in sodium citrate (20 %, w/v) compared to water and the results depicted that the hydrotropic agent did not interfere the analysis. Linearity was accessed in a range of 5-30 μg/mL and 2-12 μg/mL for cefixime and duloxetine, respectively. The methods were extensively validated and all the parameters were within the acceptance criteria with correlation of 0.999 and percentage relative standard deviation less than 2 for the estimation of both the drugs. The methods were proved to be more accurate, simple, specific, precise, robust and rapid by statistical validation, recovery studies and can be used for routine analysis.

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