R. Jain

A simple, accurate, novel, safe and precise method has been developed for estimation of poorly water soluble drug Ziprasidone Hydrochloride using 2 M Citric acid as hydrotropic agent. After solubilizing the Ziprasidone Hydrochloride in selected hydrotropic agent, it was scanned in spectrum mode and the working wavelength for the estimation, considering the reproducibility and variability was found to be 314 nm. The developed method was found to be linear in the range of 20-100 μg/ml with correlation coefficient (r2) of 0.9997. The mean percent label claims of tablets of ZIP in formulation-I and formulation-II estimated by the proposed method were found to be 97.92±0.59 and 98.46±0.39 respectively. These values are close to 100, indicating the accuracy of the proposed analytical method. Presence of hydrotropic agent do not shows any significant interference in the spectrophotometric assay thus further confirming the applicability and reproducibility of the developed method. 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.