RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF CANAGLIFLOZIN IN TABLET DOSAGE FORM

Maddu Suma,*, K. Manasa, Ch. Rajakumari and B. Lakshmaiah

In this study, we describe a simple and sensitive reversed-phase high performance liquid chromatography (HPLC) method for the determination of Canagliflozin in pharmaceutical dosage form. The chromatographic separation was achieved on ODS column (4.6 x150mm, 5μ particle size) column. The mobile phase, water and acetonitrile (55:45v/v), were delivered at a flow rate of 1.0 ml/min. The eluent was monitored using PDA detection at 214 nm. Canagliflozin was detected at 2.8 minutes. Validation parameters such as system suitability, linearity, precision, accuracy, specificity, limit of detection (LOD), limit of quantification (LOQ), Stability of sample and standard stock solutions and robustness were studied as reported in the International Conference on Harmonization guidelines. This method can be employed for routine quality control of Canagliflozin tablets in quality control laboratories and pharmaceutical industries.