同时测定制剂中尼妥吡坦和帕洛诺司琼含量的新分析方法的建立与验证

Potluri Surendra, P. Prasanna, K. Thejomoorthy
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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。通过Std Discovery C18250 x 4.6 mm, 5m进行色谱。流动相含缓冲液0.1% OPA (2.2ph):取比为55:45的乙腈,以1ml /min的流速泵入柱中。本方法使用的缓冲液为0.1% OPA。温度保持在30℃。选择的最佳波长为220 nm。尼图吡坦和帕洛诺司琼的滞留时间分别为2.308min和3.093min。尼妥吡坦和帕洛诺司琼的RSD分别为0.9和0.6。尼妥吡坦和帕洛诺司琼的回收率分别为99.51%和99.29%。尼妥吡坦和帕洛诺司琼的LOD、LOQ分别为1.84、0.01和5.59、0.03。Netupitant的回归方程为y = 7232.8x + 3439.3。,帕洛诺司琼y = 28857x + 97.732。该方法减少了停留时间,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。
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Development and Validation of New Analytical Method for The Simultaneous Estimation of Netupitant And Palonosetron In Pharmaceutical Dosage Form
A simple, Accurate, precise method was developed for the simultaneous estimation of the Netupitant and Palonosetron in Pharmaceutical dosage form. The chromatogram was run through Std Discovery C18250 x 4.6 mm, 5m. Mobile phase containing Buffer 0.1% OPA (2.2ph): Acetonitrile taken in the ratio 55:45 was pumped through the column at a flow rate of 1 ml/min. The buffer used in this method was 0.1% OPA. The temperature was maintained at 30°C. The optimized wavelength selected was 220 nm. The retention time of Netupitant and Palonosetron was found to be 2.308min and 3.093min. %RSD of the Netupitant and Palonosetron were and found to be 0.9 and 0.6 respectively. %Recovery was obtained as 99.51% and 99.29% for Netupitant and Palonosetron respectively. LOD, LOQ values obtained from regression equations of Netupitant and Palonosetron were 1.84, 0.01, and 5.59, 0.03 respectively. Regression equation of Netupitant  is y = 7232.8x + 3439.3., and y = 28857x + 97.732 of Palonosetron. Retention times were decreased and run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control tests in Industries.
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