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首页> 外文学位 >Stability-indicating method development and validation for the determination of trazodone hydrochloride and impurities/degradants in its raw material using reversed-phase liquid chromatography.
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Stability-indicating method development and validation for the determination of trazodone hydrochloride and impurities/degradants in its raw material using reversed-phase liquid chromatography.

机译：反相液相色谱法测定盐酸曲唑酮及其原料中杂质/降解物的稳定性指示方法的开发和验证。

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摘要

Trazodone hydrochloride is an antidepressant of the serotonin antagonist and reuptake inhibitor (SARI) class. It is a phenyl piperazine compound. Trazodone also has anxiolytic and hypnotic effects. Trazodone hydrochloride is a white powder, which is soluble in water and methanol. Trazodone hydrochloride underwent forced degraded under different stress conditions such as Acidic, Basic, Oxidation, Heat and UV light. This step was followed by developing a stability-indicating liquid chromatography method in which the active ingredient was separated from the potential impurities and degradants, which were obtained under different forced degradation conditions. The separation was achieved on Waters-C18 column (4.6 x 250nm, 5micro). The optimum conditions for separation were obtained using mobile phase consisting of 60% Dibasic potassium phosphate buffer (pH 7.0) and 40% Acetonitrile. The flow rate was controlled at 1.0 ml/min with an injection volume of 15-microL and detection wavelength at 248 nm. Under optimum separation conditions, the developed method was validated in terms of linearity, specificity, solution stability, robustness, accuracy, precision, limit of detection (LOD), and limit of Quantitation (LOQ) using both ICH and FDA guidelines.
机译：盐酸曲唑酮是5-羟色胺拮抗剂和再摄取抑制剂（SARI）类的抗抑郁药。它是苯基哌嗪化合物。曲唑酮还具有抗焦虑和催眠作用。盐酸曲唑酮为白色粉末，易溶于水和甲醇。盐酸曲唑酮在不同的应力条件下（例如酸性，碱性，氧化，加热和紫外线）被强制降解。此步骤之后，开发了一种指示稳定性的液相色谱方法，该方法将活性成分与在不同强制降解条件下获得的潜在杂质和降解物分离。分离是在Waters-C18色谱柱（4.6 x 250nm，5micro）上完成的。使用由60％磷酸氢二氢钾缓冲液（pH 7.0）和40％乙腈组成的流动相可获得最佳分离条件。流速控制为1.0 ml / min，进样量为15微升，检测波长为248 nm。在最佳分离条件下，使用ICH和FDA指南在线性，特异性，溶液稳定性，鲁棒性，准确性，精密度，检测限（LOD）和定量限（LOQ）方面对开发的方法进行了验证。

著录项

  • 作者

    Syed, Mohammed Nizamuddin.;

  • 作者单位

    Northeastern Illinois University.;

  • 授予单位 Northeastern Illinois University.;
  • 学科 Chemistry.
  • 学位 M.S.
  • 年度 2015
  • 页码 93 p.
  • 总页数 93
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类
  • 关键词

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