Abstract：
Margetuximab was approved for the treatment of advanced HER2+ breast cancer. A feasible analytical technique that can measure this drug was obligatory. In light of this, a novel and thoroughly validated liquid chromatographic (LC)-tandem mass spectrometric (MS/MS) approach was developed for the quantification of margetuximab in rat plasma. The liquid-liquid extraction method was used to extract the analyte from rat plasma. The analyte was separated using acetonitrile and formic acid buffer (30:70) as a mobile phase on Waters, alliance e-2695 model HPLC having Symmetry C18 column, 150 mm × 4.6 mm, 3.5-µm column. The overall runtime was 6 min at a flow rate of 1.0 ml/min. The method showed significant sensitivity and acceptable linearity over the concentration range of 6-120 ng/ml. Accuracy was within 98.51-99.92%. The intraday precision ranged between 0.41 and 8.98% CV. Also, the findings of pharmacokinetic parameters such as Cmax, tmax, AUC0-∞, AUC0-t, and half-life results of margetuximab showed that the technique was helpful for accurately measuring drug concentrations in rat plasma. The method that was developed was useful and effective for quantifying margetuximab.
摘要：
Margetuximab被批准用于治疗晚期HER2+乳腺癌。必须采用可行的分析技术来测量这种药物。鉴于此,开发了一种新颖且经过彻底验证的液相色谱（LC）-串联质谱（MS/MS）方法，用于定量大鼠血浆中的margetuximab。采用液-液提取方法从大鼠血浆中提取分析物。在Waters上使用乙腈和甲酸缓冲液（30:70）作为流动相分离分析物，具有SymmetryC18色谱柱的联盟e-2695型HPLC，150mm×4.6mm,3.5微米柱。在1.0ml/min的流速下,总运行时间为6min。该方法在6-120ng/ml的浓度范围内显示出显着的灵敏度和可接受的线性。准确率在98.51-99.92%内。日内精度介于0.41和8.98％CV之间。此外，药代动力学参数的发现，如Cmax，tmax,AUC0-∞，AUC0-t,margetuximab的半衰期结果表明，该技术有助于准确测量大鼠血浆中的药物浓度。开发的方法对于定量margetuximab是有用且有效的。
