Abstract
Objective: The present investigation is aimed to develop and validate, a simple, consistent and sensitive stability-indicating reverse phase-high performance liquid chromatography (RP-HPLC) method for the determination of oral anti-diabetic drug Canagliflozin in bulk and pharmaceutical dosage form as per the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH-Q2 (R1)). Methods: The chromatographic separation was achieved by using Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) ZORBAX C18 (250 mm x 4.6 mm, 5μm particle size) with a mobile phase consisting of Acetonitrile: Water in a ratio of 53:47% v/v at a flow rate of 1 ml/min with an injection volume of 20 μl. Results: The Retention time of the drug Canagliflozin was found to be 2.36±0.05 min and detected at 214 nm UV wavelength. The linear regression equation was found to be y = 60702x–2156.2 with a correlation coefficient 0.9999. Stress degradation studies were performed by exposing the Canagliflozin into acidic, alkaline, oxidative, thermal and photolytic stress conditions with active samples withdrawn at different time intervals as per ICH guidelines. Conclusion: The proposed Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was found to be robust, precise and specific for estimation of Canagliflozin in pharmaceutical dosage forms.
Highlights
Canagliflozin (C24H25FO5S) is chemically namedas(2S,3R,4R,5S,6R)-2[3-[[5-(4-fluoro phenyl) thiophen-2-yl] methyl]-4-methylphenyl]-6(hydroxymethyl)oxane-3,4,5-triol; hydrate, physical appearance of it is a white to off white solid with melting range of 95-105 °C It has good solubility nature in few organic solvents but poorly soluble in aqueous media [1]
Sodium-glucose co-transporter-2 (SGLT2) inhibitors are typically expressed in proximal renal tubules and is responsible for 90% re-absorption of glucose which is initially filtered by kidneys
The inhibitors of SGLT2 have been emerged as novel therapeutic approach for type 2 diabetes mellitus (T2DM) [2,3,4,5,6]
Summary
Canagliflozin (C24H25FO5S) is chemically namedas(2S,3R,4R,5S,6R)-2[3-[[5-(4-fluoro phenyl) thiophen-2-yl] methyl]-4-methylphenyl]-6(hydroxymethyl)oxane-3,4,5-triol; hydrate, physical appearance of it is a white to off white solid with melting range of 95-105 °C It has good solubility nature in few organic solvents (methanol, Dimethyl sulfoxide) but poorly soluble in aqueous media [1]. Canagliflozin is a novel oral anti-diabetic agent which belongs to a newly developed class Sodium-glucose co-transporter-2 (SGLT2) Inhibitor. Sodium-glucose co-transporter-2 (SGLT2) inhibitors are typically expressed in proximal renal tubules and is responsible for 90% re-absorption of glucose which is initially filtered by kidneys. Sodium-glucose co-transporter 2 (SGLT2) lower the reabsorption of filtered glucose into the body and decreases the renal threshold for glucose (RTG), leading to incremented urinary glucose excretion. The inhibitors of SGLT2 have been emerged as novel therapeutic approach for type 2 diabetes mellitus (T2DM) [2,3,4,5,6]. Canagliflozin (CNZ) is the first SGLT2 inhibitor approved for glycemic control in adults with T2DM. Food and Drug Administration (US FDA) approved this drug in March-2013 for treating patients having type-II diabetes [7]
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