首页> 外文期刊>Journal of Chromatographic Science >Development and Validation of a Stability-Indicating Method for the Quantitation of Paclitaxel in Pharmaceutical Dosage Forms
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Development and Validation of a Stability-Indicating Method for the Quantitation of Paclitaxel in Pharmaceutical Dosage Forms

机译:药物剂型中紫杉醇定量指示稳定性方法的开发与验证

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摘要

A simple, rapid stability-indicating isocratic assay has been developed and validated for the determination of Paclitaxel (PTX)in commercial injection formulations. The assay is performed using a Nucleosil RP-18 (5 μm, 250 ×× 4.0 mm i.d) column protected by a Nucleosil C_(18) precolumn (5 μm, 4.0 ×× 4.0 mm i.d.) with a mobile phase of methanol–water (80:20) and UV detection at 230 nm.The method was found to be specific for PTX in the presence of degradation products with an overall analytical run time of ~ 9 min. Accuracy reported as % bias was found to be 0.1–2.5% bias for all samples tested. Intra-assay precision (repeatability) was found to be 0.22–2.65% RSD, while inter-day precision (intermediate precision) was found to be 1.0–3.0% RSD for the samples studied. The calibration curve was found to be linear with the equation y = 29.78x + 7.65, and a linear regression coefficient of 0.9994 over the concentration range 0.05–20 μg/mL. The limits of quantitation and detection were 0.05 and 0.02 μg/mL, respectively. Taxol (30 mg/5 mL), a commercially available dosage form of PTX, was assayed and 100.6–103.6% of the label claim was recovered.
机译:已开发出一种简单的,指示稳定性的快速等度测定方法,并已用于商业注射制剂中紫杉醇(PTX)的测定。使用Nucleosil RP-18(5μm,250××4.0 mm内径)色谱柱进行分析,该柱由Nucleosil C_(18)预柱(5μm,4.0××4.0 mm内径)保护,流动相为甲醇-水(80:20)和230 nm的紫外线检测。发现该方法对PTX在降解产物存在下具有特异性,总分析运行时间约为9分钟。对于所有测试样品,以百分比偏差表示的准确性为0.1–2.5%。测定中样品的分析内精密度(重复性)为0.22–2.65%RSD,而日间精密度(中级精密度)为1.0–3.0%RSD。发现校准曲线与方程y = 29.78x + 7.65呈线性关系,在0.05–20μg/ mL的浓度范围内线性回归系数为0.9994。定量和检出限分别为0.05和0.02μg/ mL。测定了紫杉醇(30 mg / 5 mL),一种市售的PTX剂型,回收了100.6–103.6%的标签要求。

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