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Abstract

A new, simple, safe, accurate and reproducible titrimetric method was developed for the quantitative estimation of frusemide in the bulk drug sample and tablets by the novel application of mixed solvency concept. Ethanol has weaker solubilizing power for frusemide. The addition of 15% w/v niacinamide (a solubilizer) in ethanol showed very good solubility of frusemide (about three fold enhancement) and hence, this solvent system was employed to solubilize frusemide for its titrimetric analysis. This is a safer (non toxic) solvent system than dimethyl formamide (which is employed in pharmacopoeial method). Like this, ethanol (which is a relatively safer organic solvent) can be made a strong solvent by proper choice of solubilizers, precluding the use of hazardous, toxic organic solvents. Mixed solvency concept may be utilized to prepare the concentrated (say 30% w/v or so, in strength) combined aqueous solutions of various water-soluble additives from the categories of so called, hydrotropes (sodium benzoate, sodium ascorbate, sodium citrate, niacinamide, urea), co-solvents (glycerin, propylene glycol, ethanol, PEG 200, 300, 400, 500, 600 ), water soluble solids (PVP, PEG 4000, 6000, 8000, 10000), cyclodextrins (beta cyclodextrin, HP beta cyclodextrin) employing them in small, safe (GRAS) concentrations to solubilize the poorly water-soluble drugs to develop their dosage forms (solutions, syrups, injections, topical solutions etc) and thus, the toxicity issues of solubilizers may not raise concern (to illustrate one example, a 30% w/v aqueous solution may be made by employing 5% w/v, each, of glycerin, PVP, PEG 4000, niacinamide, HP beta cyclodextrin and tween 80).

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	JPR Solutions

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