Abstract

The use of (Netupitant and Palonosetron) combination to treat nausea and vomiting in cancer chemotherapy patients has been authorized by the Food and Drug Administration. For the simultaneous determination of Netupitant (NET) and palonosetron (PAL) in the presence of two of their related substances and in their dosage form, a sensitive and selective RP-HPLC method has been developed and validated. The aforementioned medications were separated and quantified with the help of experimental design. The Box-Behnken design was used in the experiment to optimize the chromatographic method’s analytical parameters. It employed RP-HPLC with a UV detector. Waters ODS-C₁₈ column (3.5 µm, 75 × 4.6 mm) with a mobile phase composed of acetonitrile: 25 mM phosphate buffer (pH = 3.5) in a gradient mode at 254 nm was employed to separate the cited drugs and their impurities. Palonosetron was linear over the concentration range (1–50 µg/mL) and Netupitant (10–100 µg/mL). According to ICH guidelines, the new method underwent thorough validation. Between the proposed method’s results and those from the reported method, there was no significant difference. It is easy to apply the technique to the analysis of the specified drugs in their combination dosage form for quality control considerations.

摘要

使用（奈妥匹坦和帕洛诺司琼）组合治疗癌症化疗患者的恶心和呕吐已获得美国食品和药物管理局的授权。为了同时测定两种相关物质及其剂型中的奈妥匹坦 (NET) 和帕洛诺司琼 (PAL)，我们开发并验证了一种灵敏且选择性的 RP-HPLC 方法。在实验设计的帮助下对上述药物进行了分离和定量。实验中采用Box-Behnken设计来优化色谱方法的分析参数。它采用带有 UV 检测器的 RP-HPLC。沃特世 ODS-C ₁₈采用色谱柱（3.5 µm，75 × 4.6 mm），流动相为乙腈：25 mM 磷酸盐缓冲液（pH = 3.5），梯度模式为 254 nm，用于分离所引用的药物及其杂质。帕洛诺司琼在浓度范围 (1–50 µg/mL) 和奈妥匹坦 (10–100 µg/mL) 内呈线性。根据 ICH 指南，新方法经过了彻底的验证。所提出的方法的结果与报告的方法的结果之间没有显着差异。出于质量控制考虑，很容易将该技术应用于组合剂型中特定药物的分析。