An analytical method has been developed based on a colorimetric assay for the estimation of raloxifene hydrochloride, followed by validation of the optimized method by using the ICH guidelines. The new method, aromatic ring derivatization technique, is based on a coupling reaction using modified Romini’s reagent in which sodium nitroprusside is used as a chromogenic derivatizing reagent. Raloxifene contains a phenolic hydroxyl group, containing reactive hydrogen. This reactive proton reacts with sodium nitroprusside and reduces it to sodium meta-hydrogen ferrocyano nitrate, which is a colored product. Optimization studies revealed that the coupling reaction was very rapid and completed in less than 1 minute. A 1 : 1 drug-to-reagent stoichiometric ratio was obtained for the azo dye formed. The azo adduct formed exhibits a bathochromic shift with absorption maximum λ_max at 440 nm, which was selected as the analytical wavelength. The drug seems to be linear, which was established via the regression analysis from 20 to 120μg/ml. LOD and LOQ of the developed method were found to be 1.807μg/ml and 5.47μg/ml, respectively. Interday and intraday precision was studied, and %RSD was less than 2. Since the stability of the drug and the reagent was found to be predominantly massive, this method can be used for the formulation of raloxifene hydrochloride . The method can be extended for the routine assay of raloxifene formulations.

中文翻译：

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一种简单的比色法，使用改良的Romini试剂测定药物中的雷洛昔芬盐酸盐。

已经开发了一种基于比色测定法的分析方法，用于估计雷洛昔芬盐酸盐的含量，然后通过使用ICH指南验证优化方法。新方法是芳环衍生化技术，该方法基于使用改良的Romini's试剂进行的偶联反应，其中硝普钠被用作发色衍生试剂。雷洛昔芬含有酚羟基，含有反应性氢。该反应性质子与硝普钠反应，并将其还原为有色产物偏氢氰亚铁硝酸钠。优化研究表明，偶联反应非常迅速，并在不到1分钟的时间内完成。对于形成的偶氮染料，获得了1：1的药物与试剂的化学计量比。λ_最大在440nm，将其选定为分析波长。该药物似乎是线性的，这是通过20至120μg / ml的回归分析确定的。LOD和发达方法的LOQ被发现是1.807 μ克/毫升和5.47 μ，微克/毫升分别。研究了日间和日内精度，％RSD小于2。由于发现药物和试剂的稳定性主要是块状，因此该方法可用于配制雷洛昔芬盐酸盐。该方法可扩展为雷洛昔芬制剂的常规测定。