A novel validated RP-HPLC method for the estimation of canagliflozin in bulk and pharmaceutical dosage forms

Vijaya Lakshmi Marella, Aisha Syed, Lakshmi Prasanna M, Buchi Naidu Nalluri

Abstract


The objective of the present study was to develop a simple, specific and accurate reverse phase high performance liquid chromatographic method for the determination of Canagliflozin in bulk and pharmaceutical dosage forms. The method is optimized on an inertsil ODS-3(250×4.6mm, 5µ) column with a mobile phase combination of 0.02% Formic acid: Acetonitrile (40:60) at a flow rate 1.2ml/min and the eluents were monitored at 230nm. Under these LC conditions Canagliflozin peak was eluted at 4.4 min. The developed method was validated as per ICH guidelines. The calibration curve was linear over a concentration range of 10-50µg/ml (R2 =0.999) and the mean percentage assay was found to be 98.2. The statistical data proved that proposed method is accurate, precise and reproducible. The method which is LC-MS compatible can be adopted in the routine analysis of Canagliflozin in bulk and pharmaceutical dosage forms.


Keywords


Canagliflozin, RP-HPLC Method development, Method validation

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References


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DOI: http://dx.doi.org/10.7439/ijapa.v7i3.4350

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