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首页> 外文期刊>American Journal of PharmTech Research >Development and Validation of RP-HPLC Method For Determination of Venlafaxine Hcl In Pure and Pharmaceutical Dosage Form
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Development and Validation of RP-HPLC Method For Determination of Venlafaxine Hcl In Pure and Pharmaceutical Dosage Form

机译:RP-HPLC测定纯净和药物剂型盐酸文拉法辛的方法的建立和验证

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ABSTRACT A simple, specific, accurate and precise reverse phase high performance liquid chromatographic method was developed and validated for the estimation of Venlafaxine hydrochloride in pure and Pharmaceutical dosage form. Kromasil C18 column having 150 mm x 4.6 mm internal diameter, 5 µm particle sizes in isocratic mode with mobile phase containing mixture of methanol and water in the ratio of 65:35 v/v was used. The flow rate was 1.0 ml/min and effluents were monitored at 225 nm. The retention time for Venlafaxine was 2.424 min. The method was validated for linearity, accuracy, precision, specificity, limit of detection, limit of quantification and robustness. Limit of detection and limit of quantification were found 2.97µg/ml and 9.92 µg/ml respectively and recovery of Venlafaxine from tablet formulation was found 100.4 %. The proposed method was successfully applied for the quantitative determination of Venlafaxine in tablet dosage form. Keywords: Venlafaxine, HPLC, Validation, Tablets.
机译:摘要建立了一种简单,特异,准确和精确的反相高效液相色谱方法,并经过验证可用于估计纯和药物剂型中盐酸文拉法辛。使用Kromasil C18色谱柱,该色谱柱的内径为150 mm x 4.6 mm,等度模式下粒径为5 µm,流动相含有比例为65:35 v / v的甲醇和水的混合物。流速为1.0 ml / min,并在225 nm处监测流出物。 Venlafaxine的保留时间为2.424分钟。验证了该方法的线性,准确性,精密度,特异性,检测限,定量限和稳健性。检出限和定量限分别为2.97μg/ ml和9.92μg/ ml,从片剂中回收的文拉法辛的含量为100.4%。该方法成功地用于片剂剂型中文拉法辛的定量测定。关键字:文拉法辛,HPLC,验证,片剂。

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