The present study describes the validation of a selective spectroscopic method for assay of fluvoxamine maleate (FXM). The validated method relies on condensation of FXM with 2,2‐dihydroxyindane‐1,3‐dione and phenylacetaldehyde using Teorell–Stenhagen buffer (pH 6.6) to give coloured fluorescent product measured at 482 nm using 386 nm as the excitation wavelength. The parameters influencing the reaction were studied precisely and adjusted accurately. The constructed calibration graph appeared rectilinear over the following range (0.8–14 μg ml⁻¹) and the estimated limit of detection was 0.25 μg ml⁻¹. Two pharmaceutical products from the Egyptian market were assayed using the suggested method and the final results agreed with measurements from other reported methods. Moreover, the drug was subjected to diverse stress conditions including acidic, alkaline, thermal, and photolytic degradation to examine the FXM stability. Directives from the International Conference on Harmonisation guidelines were applied to establish the validity of the work.

中文翻译：

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通过与2,2-二羟基茚满-1,3-二酮缩合进行原料药和药品中氟伏沙明稳定性研究和测定的新方法。

本研究描述了用于测定马来酸氟伏沙明（FXM）的选择性光谱方法的验证。经过验证的方法依赖于使用Teorell-Stenhagen缓冲液（pH 6.6）将FXM与2,2-二羟基茚满-1,3-二酮和苯乙醛缩合，以386 nm作为激发波长在482 nm处测得彩色荧光产物。精确研究了影响反应的参数并进行了精确调整。所构建的校准图在以下范围（0.8–14μgml ^-1）内呈直线，估计检出限为0.25μgml ^-1。使用建议的方法对埃及市场上的两种药品进行了分析，最终结果与其他报告方法的测量结果一致。此外，该药物经受了各种应激条件的考验，包括酸性，碱性，热和光解降解，以检查FXM的稳定性。应用国际协调大会准则的指令确定工作的有效性。