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建立了高效液相色谱法测定氢溴酸沃替西汀片中的有关物质,以加校正因子的自身对照法定量。使用Agilent SB-C_(18)色谱柱,流动相为乙腈∶30 mmol/L磷酸盐缓冲液(用磷酸调至pH 3.2),线性梯度洗脱,检测波长226 nm。计算有关物质的相对校正因子(RCF),以此计算有关物质含量,并与对照品法测定结果比较,以验证方法的准确性。结果有关物质A(S-氧化物)、B(N-甲酰化物)的相对保留时间为0.35、2.37,RCF为1.29、0.80。RCF法与对照品法测定结果无显著性差异。通过方法学验证,沃替西汀和这2个杂质的分离度良好,均在0.2~20mg/ml范围内线性关系良好。有关物质A和B的平均加样回收率为99.2%和101.3%,RSD为1.2%和0.9%。该方法简单易行,可准确测定沃替西汀片剂中有关物质。
A high performance liquid chromatographic method was established for the determination of related substances in Wortezin hydrobromide tablets and quantified by self-control method with correction factor. The Agilent SB-C_ (18) column was used with a mobile phase of acetonitrile: 30 mmol / L phosphate buffer (adjusted to pH 3.2 with phosphoric acid) and linear gradient elution with a detection wavelength of 226 nm. Calculate the Relative Correction Factor (RCF) of the relevant substances to calculate the relevant substance content, and compared with the results of the reference method to verify the accuracy of the method. Results The relative retention time of substance A (S-oxide), B (N-formyl) was 0.35, 2.37 and the RCF was 1.29, 0.80. There was no significant difference between RCF method and control method. The validation of the methodologies showed good linearity between the values of vortioxetine and these two impurities in the range of 0.2-20 mg / ml. The average recoveries for substances A and B were 99.2% and 101.3% with RSDs of 1.2% and 0.9%, respectively. The method is simple and easy, and can accurately determine the related substances in the tablet of vortioxetine.