尼达尼布 (NTB) 是一种多重酪氨酸激酶抑制剂，已被研究用于治疗多种疾病，如特发性肺纤维化 (IPF)、系统性硬化性间质性肺疾病 (SSc-ILD) 和非小细胞肺癌 (NSCLC)。 NTB 可作为口服胶囊制剂使用，但其检测通过氧化、光解和水解过程形成的降解物的能力使其难以量化。本工作开发并验证了一种新型反相高效液相色谱（RP-HPLC）方法。该方法简单、精密、重现性好、稳定、准确。使用所提出的分析方法评估了 NTB 的固有稳定性，并进行了力退化研究。 NTB 在 Shimadzu C 18 柱作为固定相 (250 ×4.6 mm, 5 µm) 上采用等度洗脱法进行色谱分离，使用 0.1% v/v 三乙胺 (TEA) 的 HPLC 级水和乙腈 (ACN) 溶液（按比例） 35:65% v/v。以 1.0 ml/min 恒定流速泵入流动相，在 390 nm 波长下检测洗脱液。NTB 在保留时间 (t R) 6.77±0.00 min 时洗脱，相关系数为 0.999，开发的方法在 0.5 µg/ml 至 4.5 µg/ml 的浓度范围内呈线性。对于 1.5 µg/ml 浓度，回收率在 99.391±0.468% 范围内。确定六个重复标准品的 % RSD 为 0.04。配方赋形剂不会干扰 NTB 的测定，证明了所开发方法的特异性。所提出的分析方法可用于量化原料药和药物制剂中 NTB 的含量。版权所有：© 2024 Velagacherla V 等人。

Nintedanib (NTB) is a multiple tyrosine kinase inhibitor, been investigated for many disease conditions like idiopathic pulmonary fibrosis (IPF), systemic sclerosis interstitial lung disease (SSc-ILD) and non-small cell lung cancer (NSCLC). NTB is available as oral capsule formulation, but its ability to detect degradants formed through oxidative, photolytic and hydrolytic processes makes it difficult to quantify. In the current work, a novel reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated.The developed method is simple, precise, reproducible, stable and accurate. The inherent stability of NTB was evaluated using the proposed analytical method approach and force degradation studies were carried out. NTB was separated chromatographically on the Shimadzu C 18 column as stationary phase (250 ×4.6 mm, 5 µm) using an isocratic elution method with 0.1% v/v triethyl amine (TEA) in HPLC grade water and acetonitrile (ACN) in the ratio 35:65% v/v. The mobile phase was pumped at a constant flow rate of 1.0 ml/min, and the eluent was detected at 390 nm wavelength.NTB was eluted at 6.77±0.00 min of retention time (t R) with a correlation coefficient of 0.999, the developed method was linear in the concentration range of 0.5 µg/ml to 4.5 µg/ml. The recovery rate was found to be in the range of 99.391±0.468% for 1.5 µg/ml concentration. Six replicate standards were determined to have an % RSD of 0.04.The formulation excipients didn't interfere with the determination of NTB, demonstrating the specificity of the developed method. The proposed approach of the analytical method developed can be used to quantify the amount of NTB present in bulk drugs and pharmaceutical formulations.Copyright: © 2024 Velagacherla V et al.