DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF CANAGLIFLOZIN AND METFORMIN BY RP-HPLC IN BULK FORM AND MARKETED PHARMACEUTICAL DOSAGE FORM

Abstract

Canagliflozin and Metformin RP-HPLC Bulk and
Combined Dosage Form Analytical Method
Development and Validation, Canagliflozin and
Metformin concentrations were determined
concurrently using a novel RP-HPLC technique.
Using Symmetry ODS C18 (4.6mm 250mm, 5m)
at a flow rate of 1.0 ml/min and a mobile phase
ratio of (70:30 v/v), the optimum
chromatographic conditions for the separation
of Canagliflozin and Metformin were created.
The detection wavelength was 250 nm, and the
buffer was methanol: TEA at pH 3.8 (pH was
modified with orthophosphoric acid). WATERS
Alliance 2695 separation module with Empower
2, 996 PDA detector was utilized for this
experiment. 2.246 and 5.461 minutes were
calculated to be the retention times.
Canagliflozin had a purity of 101.27 percent,
whereas Metformin was determined to be 99.7
percent pure. Canagliflozin and Metformin both
have a resolution of 2.97, whereas other system
appropriateness metrics such as theoretical
plates and tailing factor are 5387 and 0.97,
respectively. According to ICH rules (ICH,
Q2 (R1)). Canagliflozin and metformin were
both shown to be linear throughout a
concentration range of 30–70 mg and 60–140
mg, respectively, with correlation coefficients
(r2) of 0.999 and 0.999, respectively.
Results showed a recovery rate of 100.14%, a
repeatability error of 0.14%, and an
intermediate precision error of 0.14%. Accurate,
solid, and reproducible results were found in
the precision investigation. Both the LOD and
LOQ values were quite high: 0.56 and 1.2, and
1.7 and 3.6, respectively. Therefore,
Canagliflozin and Metformin in API and
Pharmaceutical dosage form may be routinely
analyzed with the proposed RP-HPLC approach.