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Asian Journal of Pharmaceutical Analysis
Year : 2018, Volume : 8, Issue : 4
First page : ( 186) Last page : ( 190)
Print ISSN : 2231-5667. Online ISSN : 2231-5675.
Article DOI : 10.5958/2231-5675.2018.00034.0

Method Development and Validation of Alectinib Drug by RP-HPLC in Bulk and Pharmaceutical Dosage Form

Prashanthi Y.1, Rao Tentu Nageswara2,*, Srinivas Yellapu3

1Department of Biochemistry, Acharya Nagarjuna University, Andhra Pradesh, India

2Department of Chemistry, Mahatma Gandhi University, Nalgonda, Telangana, India

3Mother Degree & P.G College, Tuni, A.P, India

*Corresponding Author E-mail: tnraochemistry@gmail.com

Online published on 25 December, 2018.

Abstract

In this study we developed and validated an isocratic Reversed Phase High Performance Liquid Chromatography method with PDA detection for the estimation of Alectinib drug. The method was selective and is capable of detecting at traces levels in the drug substance. The method was validated on an Inertia ODS C18 analytical column (4.6 X 150 mm, 5 μm), mobile phase consisting of Methanol: phosphate buffer at pH 3 in the ratio of 70: 30% v/v. The flow rate was at 1 ml/min and the column was maintained at ambient temperature condition. The detector using photo diode array was set at a wavelength of 265 nm. Calibration plot was linear in concentration range of 10–50 ppm levels with the correlation coefficient (r2) of 0.999. The intra and inter-day precision% RSD values were 0.48 and 0.51% respectively. The Limit of Detection and Limit of Quantification values were found to be 0.77 μg/mland 2.35 μg/ml respectively. The method was validated in terms of system precision, method precision, linearity, accuracy, limit of detection, quantification and robustness. Due to its speed and accuracy, this method can be used for estimation and analysis of Alectinib drug in Active Pharmaceutical Ingredients and Pharmaceuticals.

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Keywords

Alectinib, Alecensa, Reversed Phase High Performance Liquid Chromatography, Estimation, Photo Diode Array detector.

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