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首页> 外文期刊>American Journal of PharmTech Research >Novel Ecofriendly Spectrophotometric Method for Estimation of Ziprasidone Hydrochloride Monohydrate using Hydrotropic Solubilization Technique
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Novel Ecofriendly Spectrophotometric Method for Estimation of Ziprasidone Hydrochloride Monohydrate using Hydrotropic Solubilization Technique

机译：水溶增溶法估算盐酸齐普拉西酮一水合物的新型环保分光光度法

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摘要

  ABSTRACT 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.
机译：摘要已经开发出一种简单，准确，新颖，安全和精确的方法，以2 M柠檬酸为水溶助剂来评估水溶性差的药物盐酸齐普拉酮。考虑到重现性和变异性为314 nm，在选定的水溶助剂中溶解了盐酸齐普西酮后，对其进行了光谱模式和工作波长扫描以进行估计。发现所开发的方法在20-100μg/ ml范围内呈线性，相关系数（r2）为0.9997。通过本发明方法估计的制剂I和制剂II中ZIP片剂的平均标签要求百分比分别为97.92±0.59和98.46±0.39。这些值接近100，表明所提出的分析方法的准确性。水溶助剂的存在在分光光度测定中没有显示任何明显的干扰，因此进一步证实了所开发方法的适用性和可重复性。根据ICH指南对开发的方法进行了验证，发现准确性，精密度和其他统计分析的值与规定值完全一致。

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