Research Article on Development and Validation of RP-HPLC Method for Estimation of Canagliflozin

Gudipally Mounika, K Bhavya Sri, R Swethasri, M Sumakanth

Abstract


To develop an accurate, precise, specific high performance liquid
chromatography method for quantification of Canagliflozin in bulk and dosage
forms. A C18 column (250mm X 4.6mm; 5μm phenomenex) was used with
mobile phase containing Acetonitrile-0.1% sodium acetate buffer (pH-4.6),
(20:80) in isocratic mode. The flow rate maintained was 1.0ml/min and the
U.V detector was operated at 291nm. The retention time of Canagliflozin was
3.307min and showed a good linearity in concentration range of 2-14μg/ml
with correlation coefficient of 0.999. The average percent recovery was found
to be 99.98%. The developed method follows validation parameters such as
system suitability, linearity, precision, accuracy, limit of detection and limit of
quantification and robustness as per ICH guidelinesQ2(R1). The proposed
method was found to provide faster retention time with sharp resolution with
linearity at a lowest concentration as compared to previous methods and this
method is validated as per International conference on harmonization
guidelines and successfully applied for bulk and pharmaceutical dosage form.

Keywords


Canagliflozin, RPHPLC, retention time, Correlation coefficient validation, ICH guidelinesQ2 (R1).

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DOI: https://doi.org/10.18090/samriddhi.v11i02.2

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