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New, sensitive and validated HPLC method for simultaneous estimation of venlafaxine and o-desmethylvenlafaxine using fluorescence detector

机译:通过荧光检测器同时估算文拉法辛和邻去甲基文拉法辛的灵敏性和高效液相色谱新方法

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摘要

A rapid, sensitive, specific, accurate and precise reverse phase high performance liquid chromatographic method (RP-HPLC) has been developed and validated for the simultaneous estimation of venlafaxine (VEN) and o-desmethylvenlafaxine (ODV) in tablet dosage forms. The column used is Agilent Eclipse XDB-C18 column (150 x 4.6 mm, 5 μm) in low pressure gradient mode with mobile phase containing 0.01 M potassium dihydrogen or-thophosphate: acetonitrile (75:25 v/v; pH 4.5). The mobile phase was pumped at 1.0 ml/min with fluorescence detection at excitation wavelength of 226 nm and emission wavelength of 298 nm. The proposed method has been validated with linear range of 0.1 - 8 μg/mL for both VEN and ODV. The % Bias (Accuracy), intra- batch and inter- batch precision values were within ±2% RSD. Limit of detection of VEN and ODV were found to be 0.002 and 0.005 μg/mL, respectively and limit of quantification of VEN and ODV were found to be 0.007 and 0.015 μg/mL, respectively. Total run time was short being 10 min only. Proposed method has been successfully applied for the quantitative determination of VEN and ODV in tablet dosage forms.
机译:已开发出一种快速,灵敏,特异,准确和精确的反相高效液相色谱方法(RP-HPLC),并经过验证可同时估计片剂剂型中的文拉法辛(VEN)和邻去甲基文拉法辛(ODV)。所用的色谱柱为低压梯度模式下的Agilent Eclipse XDB-C18色谱柱(150 x 4.6 mm,5μm),流动相含有0.01 M的正磷酸二氢钾和正磷酸:乙腈(75:25 v / v; pH 4.5)。泵浦流动相,流速为1.0 ml / min,在226 nm激发波长和298 nm发射波长下进行荧光检测。 VEN和ODV的线性范围为0.1-8μg/ mL时,已验证了该方法的有效性。偏差百分比(准确度),批内和批间精度值均在±2%RSD之内。发现VEN和ODV的检出限分别为0.002和0.005μg/ mL,发现VEN和ODV的定量限分别为0.007和0.015μg/ mL。总运行时间很短,只有10分钟。所建议的方法已成功地用于片剂剂型中VEN和ODV的定量测定。

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