反相高效液相色谱法同时测定尼妥吡坦和帕洛诺司琼原料药和制剂的稳定性指示方法的建立与验证

Harshini Gandla, M. Ajitha
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引用次数: 1

摘要

建立了一种简便、准确、精确的同时测定药物剂型中尼妥吡坦和帕洛诺司琼含量的方法。色谱柱为Phenomenex C18 150mm (4.6 × 150mm, 5μm)流动相,含缓冲液60% 0.01N KH2PO4: 40%乙腈,以1 ml/min的流速泵入柱内。温度保持在30°C。优选波长为230.0 nm。帕洛诺司琼和帕洛诺司琼的滞留时间分别为2.266 min和2.945 min,尼图吡坦和帕洛诺司琼的%RSD分别为0.8和0.8。尼妥吡坦和帕洛诺司琼的回收率分别为101.08%和100.35%。由尼妥吡坦和帕洛诺司琼的回归方程得到的LOD、LOQ分别为1.27、3.86和0.002、0.006。分别。Netupitant的回归方程为y =18431x + 50471。y = 13091x + 11.98。Palonosetron。该方法减少了滞留时间,缩短了运行时间,简便、经济,可用于工业中常规的质量控制试验。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Stability Indicating Method Development and Validation for Simultaneous Estimation of the Netupitant and Palonosetron in Bulk and Pharmaceutical Dosage Form by RP-HPLC
A simple, Accurate, precise method was developed for the simultaneous estimation of the Netupitant and Palonosetron in Pharmaceutical dosage form. Chromatogram was run through Phenomenex C18 150 mm (4.6 x 150mm, 5μm) Mobile phase containing Buffer 60% 0.01N KH2PO4: 40% Acetonitrile was pumped through column at a flow rate of 1 ml/min. Temperature was maintained at 30°C. Optimized wavelength selected was 230.0 nm. Retention time of Palonosetron and Netupitant were found to be 2.266 min and 2.945 min. %RSD of the Netupitant and Palonosetron were and found to be 0.8 and 0.8 respectively. %Recovery was obtained as 101.08% and 100.35%for Netupitant and Palonosetron respectively. LOD, LOQ values obtained from regression equations of Netupitant and Palonosetron were 1.27, 3.86 and 0.002, 0.006. respectively. Regression equation of Netupitant is y =18431x + 50471.and y = 13091x + 11.98. of Palonosetron. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.
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