Development And Validation Of Rp-Hplc For Estimation Of Neratinib In Bulk And Tablet Dosage Form
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Date
2019-03
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Publisher
MRI Publication Pvt. Ltd.
Abstract
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 Altima column (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 the effluents 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.
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Keywords
Neratinib, antineoplastic activity, ICH Guidelines, method validation
Citation
Lakshmi Kanth M., Raj Kamal B. Development And Validation Of Rp-Hplc For Estimation Of Neratinib In Bulk And Tablet Dosage Form. International Journal of Pharmaceutical Sciences and Drug Research. 2019 Mar; 11(2): 56-60