Souri Effat, Donyayi Hassan, Khaniha Reza Ahmad, Barazandeh Tehrani Maliheh
Department of Medicinal Chemistry, School of Pharmacy and Drug Design and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Department of Human Ecology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.
Iran J Pharm Res. 2015 Fall;14(4):1059-65.
Fluvoxamine maleate is a selective serotonin reuptake inhibitor, which is used for the treatment of different types of depressive disorders. In the present study, a stability indicating HPLC method was developed and validated for the determination of fluvoxamine maleate. The chromatographic separation was carried out using a Nova-Pak CN column and a mixture of K2HPO4 50 mM (pH 7.0) and acetonitrile (60: 40, v/v) as the mobile phase. Target compounds were detected using a UV detector set at 235 nm. The developed method was linear over the concentration range of 1-80 μg/ml with acceptable precision (CV values < 2.0%) and accuracy (error values < 1.6%). The degradation studies showed that fluvoxamine maleate is relatively unstable under acidic, basic and oxidative conditions and also when exposed to UV radiation. On the other hand, the bulk powder of fluvoxamine maleate was relatively stable when exposed to visible light or heat. The proposed method was successfully applied for the determination of active ingredient of fluvoxamine dosage form without any interference from tablet excipients.
马来酸氟伏沙明是一种选择性5-羟色胺再摄取抑制剂，用于治疗不同类型的抑郁症。在本研究中，开发并验证了一种用于测定马来酸氟伏沙明的稳定性指示高效液相色谱法。色谱分离使用Nova-Pak CN柱，以50 mM磷酸氢二钾（pH 7.0）和乙腈（60:40，v/v）的混合物作为流动相。使用设置在235 nm的紫外检测器检测目标化合物。所开发的方法在1-80 μg/ml的浓度范围内呈线性，具有可接受的精密度（CV值<2.0%）和准确度（误差值<1.6%）。降解研究表明，马来酸氟伏沙明在酸性、碱性和氧化条件下以及暴露于紫外线辐射时相对不稳定。另一方面，马来酸氟伏沙明的原料药在暴露于可见光或热时相对稳定。所提出的方法成功应用于测定氟伏沙明剂型的活性成分，不受片剂辅料的任何干扰。
