An RP-HPLC method is validated to separate and quantify flubendiamide and its relevant eight related
impurities. The ideal chromatographic separation of flubendiamide and its eight allied impurities was
performed on Ace-5 C-18 column (5 μm, 25 cm × 4.6 mm) with formic acid (0.1%) in Milli-Q water
plus acetonitrile in a gradient elution at a flowing rate of 1.2 mL/min as mobile phase. Photodiode array
based detection at wavelength of 240 nm was deployed to monitor flubendiamide and its eight related
impurities. The robustness, accuracy, linearity, precision and detection and quantitation limitations of
the new RP-HPLC technique for flubendiamide and its eight related impurities were all validated.
Both FDE and eight process allied impurities had quantitation limits in the range of 0.07 to 0.12
μg/mL. This new HPLC technique was successfully applied to ascertain the purity of flubendiamide
analyte and levels of eight related impurities in five bulk lot products of flubendiamide synthesized in
the laboratory. The present study also deals with the bulk batch synthesis of flubendiamide and
characterization of flubendiamide and its relevant eight impurities by 1H NMR, ESI-MS and IR
spectroscopy.
采用 RP-HPLC 方法对氟苯酰胺及其相关的八个杂质进行分离和定量。
杂质。在 Ace-5 C-18 色谱柱(5 μm×25 cm×4.6 mm)上对氟苯地胺及其八种相关杂质进行了理想的色谱分离。
采用 Ace-5 C-18 色谱柱(5 μm,25 cm × 4.6 mm),甲酸(0.1%)溶于毫升水和乙腈。
加乙腈进行梯度洗脱,流动相流速为 1.2 mL/min。光电二极管阵列
光电二极管阵列检测波长为 240 nm,用于监测氟苯地米及其八种相关杂质。
杂质。新的 RP-HPLC 技术的稳健性、准确性、线性度、精密度、检测和定量限制
对氟苯地胺及其八种相关杂质的新型 RP-HPLC 技术的稳健性、准确性、线性度、精确度以及检测和定量限制进行了验证。
氟苯尼考和八种相关杂质的定量限在 0.07 至 0.12 μ/mL 之间。
微克/毫升。这一新的高效液相色谱技术成功地应用于确定氟苯甲酰胺分析物的纯度和八种相关杂质的含量。
分析物的纯度以及实验室合成的五批次氟苯甲酰胺散装产品中八种相关杂质的含量。
实验室合成的五种批量氟苯地胺产品中氟苯地胺本研究还涉及氟苯地胺的批量合成和
通过 1H NMR、ESI-MS 和 IR
光谱进行表征。