This study was designed to develop and validate hydrotropic agent and dye drug reaction methods for estimation of diacerein in capsule formulation. Hydrotropic solubilization is a technique used to increase the aqueous solubility of poorly water-soluble drugs and the present study was aimed at developing a hydrotropic technique to increase the solubility of diacerein. The analysis of tablets indicated good correlation between the amounts estimated and label claim. The study results indicate good sensitivity of the proposed method. The results of analysis were validated statistically and by recovery studies. The developed methods were validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. Thus the proposed method was found to be simple, environmentally friendly, accurate and cost effective and can be successfully employed in routine analysis of diacerein in capsule.

Hydrotropic Solubilizing Agents, Diacerein, Dye Drug Reaction, ICH, validation

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