A Novel Application of Hydrotropic Solubilization for Simultaneous Estimation and Validation of Acetaminophen, Chlorzoxazone, and Aceclofenac in Tablet Dosage Form
By Rajesh Sharma, Pandurang Gaikwad, Rupali Joshi
Various organic solvents like methanol, chloroform, alcohol, dimethyl formamide; acetonitrile, hexane, acetone and carbon tetrachloride have been employed for solubilization of poorly water-soluble drugs for spectrophotometric estimations. Drawbacks of organic solvents include high cost and error in analysis due to volatility. Attempting to minimize these drawbacks, three new, simple, accurate, environmental friendly, cost effective, safe, sensitive spectrophotometric methods have been developed for simultaneous estimation acetaminophen, chlorzoxazone, and aceclofenac in tablet dosage form by using 8.0 M urea solution, as a hydrotropic agent. Aqueous solubility of these model drugs were enhanced to a great extent 18, 5 and 10 fold for acetaminophen, chlorzoxazone, and aceclofenac in 8.0M urea solution respectively. Urea solution and additives of tablet did not interfere in analysis, as urea did not show any absorbance above 243nm. In 8.0M urea solution, acetaminophen, chlorzoxazone, and aceclofenac show maximum absorbance at wavelength 244.4nm, 281.6 and 276.0nm respectively. Beer’s law was obeyed in the concentration range 0-40µg/ml for three drugs. Method-I is based on simultaneous equation method, method-II is area under curve and method III is multi-component methods of spectrophotometric analysis. Results of analysis for these methods were tested and validated for various parameters according to ICH guidelines, hence can be adopted for the routine analysis of acetaminophen, chlorzoxazone, and aceclofenac in tablet dosage form.
Keywords : Hydrotropic Solubilization, Acetaminophen, Chlorzoxazone, Aceclofenac, Spectrophotometry, ICH guidelines.