Abstract

Shyni Bernard*, Rana Razak P. C., Bindhu R., Reshma Suresh and Sahal C.

ABSTRACT

Background: Solubility is the major problem for drugs in pharmaceutical industry.Various organic solvents such as methanol, chloroform, dimethyl formamide andacetonitrile have been employed for solubilization of poorly water-soluble drugs tocarry out spectrophotometric analysis. Drawbacks of organic solvents include theirhigher cost, toxicity and pollution. Hydrotropy is a unique solubilization techniquein which certain chemical compounds termed as hydrotropes can be used to affect aseveral fold increase in the aqueous solubility of sparingly soluble solutes undernormal conditions due to the formation of organized assemblies of hydrotropemolecules at critical concentrations. Hydrotropic solubilization may be a properchoice to preclude the use of organic solvents. Method: A novel, simple, fast andreproducible UV spectrophotometric method was developed using 2.5M ureasolution as hydrotropic solubilizing agent for the estimation of poorly water solubledrug glimepiride in bulk and in pharmaceutical dosage form. Glimepiride exhibitsabsorption maximum at 235 nm. Urea did not show any absorbance above 225 nmand thus no interference in the estimation of drug was seen. Results: The results ofanalysis have been validated as per ICH guidelines. Beer’s law was found to beobeyed in the concentration range of 5-40μg/ml. In this method, there is nointerference from any common pharmaceutical additives and diluents. Thecorrelation co-efficient (' r ' value) for glimepiride was found to be 0.99983. Thepercentage recovery obtained for glimepiride ranges from 99.30 % to 99.99%. Thedeveloped method is accurate, precise and economical.