Open AccessDevelopment and Validation of RP-HPLC for Estimation of Neratinib in Bulk and Tablet Dosage Form
Author(s) -
M Lakshmi Kanth,
B. Raj Kamal
Publication year - 2019
Publication title -
international journal of pharmaceutical sciences and drug research
Language(s) - English
Resource type - Journals
ISSN - 0975-248X
DOI - 10.25004/ijpsdr.2019.110202
Subject(s) - chromatography , neratinib , formic acid , acetonitrile , high performance liquid chromatography , chemistry , phosphate buffered saline , retention time , linear regression , linearity , dosage form , mathematics , materials science , statistics , medicine , physics , trastuzumab , cancer , quantum mechanics , breast cancer
An accurate RP-HPLC method developed for the estimation of Neratinib in bulk and tablet dosage form. The method is and validated for parameters linearity, accuracy, suitability, specificity, precession, LOD, LOQ and robustness. An Altimacolumn (150 mm × 4.6 mm × 5μ) used for chromatographic separation within a runtime of 6 min. The mobile phase buffer (monopotassium phosphate) and acetonitrile (60:40 v/v) with 0.1% formic acid is used. The flow rate maintained at 1.0 ml/min with theeffluents monitored at 215 nm. The Neratinib analyzed at retention time of 4.001. The concentration linear over 30-180μg/ml with regression equation y = 6065.6x + 795.43 and regression co-efficient 0.999.