Method development and validation for simultaneous estimation of netupitant and palonosetron in bulk and pharmaceutical dosage form by using RP-HPLC

S. Siddiraju, Akshay, M. Sudhakar
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Abstract

A simple, Accurate, precise method was developed for the simultaneous estimation of the Netupitant and Palanosetron in Tablet dosage form. Chromatogram was run through Std Discovery C18 250 x 4.6 mm, 5. Mobile phase containing Buffer 0.1% OPA (2.2ph): Acetonitrile taken in the ratio 55:45 was pumped through column at a flow rate of 1 ml/min. Buffer used in this method was 0.1% OPA. Temperature was maintained at 30°C. Optimized wavelength selected was 230 nm. Retention time of Netupitant and Palanosetron were found to be 2.325min and 3.026min. %RSD of the Netupitant and Palanosetron were and found to be 0.9 and 0.6 respectively. %Recovery was obtained as 100.28% and 99.76% for Netupitant and Palanosetron respectively. LOD, LOQ values obtained from regressionequations of Netupitant and Palanosetron were 1.01, 3.05 and 0.001, 0.003 respectively. Regression equation of Netupitant is y = 13900x + 26511, and y = 563617x + 1740.8 of Palanosetron. 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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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方法建立与验证
建立了一种简便、准确、精确的同时测定片剂中尼妥吡坦和帕拉司琼含量的方法。色谱通过Std Discovery C18 250 x 4.6 mm, 5。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。本方法所用缓冲液为0.1% OPA。温度保持在30°C。优选波长为230 nm。尼妥吡坦和帕拉司琼的滞留时间分别为2.325min和3.026min。尼妥吡坦和帕拉司琼的RSD分别为0.9和0.6。尼妥吡坦和帕拉诺司琼的回收率分别为100.28%和99.76%。尼妥吡坦和帕拉司琼的LOD、LOQ分别为1.01、3.05和0.001、0.003。Netupitant的回归方程为y = 13900x + 26511, Palanosetron的回归方程为y = 563617x + 1740.8。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。
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