Jain Ruchi, Jain Nilesh, Jain Deepak Kumar, Jain Surendra Kumar
Suresh Gyan Vihar University, Jaipur, Rajasthan, India-302025.
Adv Pharm Bull. 2013;3(2):409-13. doi: 10.5681/apb.2013.065. Epub 2013 Aug 20.
Analysis of drug utilized the organic solvent which are costlier, toxic and causing environment pollution. Hydrotropic solution may be a proper choice to preclude the use of organic solvents so that a simple, accurate, novel, safe and precise method has been developed for estimation of poorly water soluble drug Entacapone (Water Solubility-7.97e-(02) g/l).
Solubility of entacapone is increased by using 8M Urea as hydrotropic agent. There was more than 67 fold solubility enhanced in hydrotropic solution as compare with distilled water. The entacapone (ENT) shows the maximum absorbance at 378 nm. At this wavelength hydrotropic agent and other tablet excipients do not shows any significant interference in the spectrophotometric assay.
The developed method was found to be linear in the range of 4-20 μg/ml with correlation coefficient (r(2)) of 0.9998. The mean percent label claims of tablets of ENT in tablet dosage form estimated by the proposed method were found to be 99.17±0.63. 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.
As hydrotropic agent used in the proposed method so this method is Ecofriendly and it can be used in routine quantitative analysis of drug in bulk drug and dosage form in industries.
分析药物使用的有机溶剂成本更高、有毒且会造成环境污染。助溶剂溶液可能是避免使用有机溶剂的合适选择，因此已开发出一种简单、准确、新颖、安全且精确的方法来测定水溶性差的药物恩他卡朋（水溶性 - 7.97e-(02) g/l）。
使用8M尿素作为助溶剂来提高恩他卡朋的溶解度。与蒸馏水相比，助溶剂溶液中的溶解度提高了67倍以上。恩他卡朋（ENT）在378nm处显示最大吸光度。在此波长下，助溶剂和其他片剂辅料在分光光度法测定中未显示任何显著干扰。
所开发的方法在4 - 20μg/ml范围内呈线性，相关系数（r(2)）为0.9998。通过所提出的方法估计的片剂剂型中ENT片剂的平均标示量百分比为99.17±0.63。所开发的方法根据ICH指南进行了验证，准确性、精密度和其他统计分析的值与规定值非常一致。
由于在所提出的方法中使用了助溶剂，因此该方法对环境友好，可用于工业中原料药和剂型中药物的常规定量分析。
