Abstract
Objective: This method is focused on developing a precisely simplified and more accurate Reverse Phase–High Pressure Liquid Chromatography (RP-HPLC) method for the determination of Dapagliflozin in bulk and pharmaceutical dosage form as per guidelines of International Council for Harmonization (ICH). Methods: Evaluation and validation carried out using the RP-HPLC ZORBAX (C18) column (250 x 4.6 mm, 5 μm particle size) with a mobile phase consisting of Phosphate Buffer: Acetonitrile: Methanol in a ratio of 55:40:05 (v/v/v) at a flow rate of 1 ml/min with an injection volume of 10 μl. Results: Dapagliflozin was eluted at 2.12±0.05 min and detected at 225 nm. The regression equation y = 55762 x-29679 found to be linear with correlation coefficient r2 value of 0.9997. The developed RP-HPLC method was conveniently validated as per the ICH guidelines and found method was robust, sensitive, accurate, selective, specific, precise and linear. Conclusion: The proposed method was found to be accurate, precise, and robust for API and pharmaceutical dosage form as per experimentation analysis. The above developed method was found to be satisfied for Active Pharmaceutical Ingredient (API) and pharmaceutical formulation of Dapagliflozin to study its degradation products.
Highlights
Dapagliflozin (C21H25ClO6) is chemically namedas (1S)-1, 5-anhydro1-C-[4-chloro-3-[(4-ethoxyphenyl) methyl] phenyl]-D-glucitol, physical appearance of it is a white to off white solid with melting range of 74-78 °C
Dapagliflozin is an oral anti-diabetic agent which belongs to Selective Sodium-glucose co-transporter-2 (SGLT2) Inhibitor
Sodium-glucose co-transporter-2 (SGLT2) inhibitors are expressed in proximal renal tubules and are responsible for 90% reabsorption of glucose filtered by kidneys
Summary
Dapagliflozin (C21H25ClO6) is chemically namedas (1S)-1, 5-anhydro1-C-[4-chloro-3-[(4-ethoxyphenyl) methyl] phenyl]-D-glucitol, physical appearance of it is a white to off white solid with melting range of 74-78 °C. It has a good solubility profile in organic solvents such as methanol, and dimethyl sulfoxide but is poorly soluble in aqueous media. Dapagliflozin is an oral anti-diabetic agent which belongs to Selective Sodium-glucose co-transporter-2 (SGLT2) Inhibitor. Sodium-glucose co-transporter-2 (SGLT2) inhibitors are expressed in proximal renal tubules and are responsible for 90% reabsorption of glucose filtered by kidneys. Sodium-glucose co-transporter 2 (SGLT2) lowers reabsorption of filtered glucose into the body by decreasing the renal threshold for glucose (RTG) which leads to the production of a supplement to urinary glucose excretion in diabetic patients [1, 2]. Dapagliflozin is a C-glycosyl comprising beta-Dglucose in which the anomeric hydroxyl group is replaced by a 4chloro-3-(4-ethoxybenzyl) phenyl group to improve glycemic control in adults with type 2 diabetes along with improved lifestyle. Adults with proper diet and exercise showed improved glycemic control by Gliflozin derivatives by inhibiting glucose resorption in the proximal tubule of the nephron and causing glycosuria [2, 3]
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