Abstract
Objective: The present study aims at developing an accurate precise, rapid and sensitive Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for assessing Empagliflozin in bulk drug and in the pharmaceutical dosage form.
 Methods: The proposed method employs a Reverse Phase Shim Pack C18 column (250 mm × 4.6 mm id; 5 µm) using a mobile phase comprising of acetonitrile and water in the ratio of 60:40 v/v flushed at a flow rate of 1 ml/min. The eluents were monitored at 223 nm.
 Results: Empagliflozin was eluted at a retention time of 5.417 min and established a co-relation co-efficient (R2>0.999) over a concentration ranging from 0.0495-100µg/ml. Percentage recovery was obtained between 98-102% which indicated that the method is accurate. The Limit of Detection (LOD) and Limit of Quantitation (LOQ) were found at 0.0125µg/ml and 0.0495µg/ml, respectively.
 Conclusion: An RP-HPLC method which was relatively simple, accurate, rapid and precise was developed and its validation was performed for the quantitative analysis of empagliflozin in bulk and tablet dosage form (10 and 25 mg) in accordance to International Conference of Harmonization (ICH) Q2 (R1) guidelines. The proposed method may aid in routinely analyzing empagliflozin in pharmaceuticals.
Highlights
Type 2 Diabetes mellitus (T2DM) is a popular chronic metabolic disorder caused by insulin insensitivity and decreased level of insulin secretion
The proposed method was designed by optimizing the chromatographic conditions by pertaining to various trial runs altering the mobile phase composition, the ratio of the mobile phase, pH, column, column length to attain symmetrical analyte peak at a sufficiently short run time
Asymmetric analyte peak with an acceptable short run time was achieved employing acetonitrile and water in a ratio of 40:60 v/v at a flow rate of 1 ml/min, with a Shim pack C18 (250 mm X 4.6 mm, 5 μm) being utilized as the stationary phase and the eluents were monitored at a wavelength of 223 nm
Summary
Type 2 Diabetes mellitus (T2DM) is a popular chronic metabolic disorder caused by insulin insensitivity and decreased level of insulin secretion. Diabetes mellitus is accompanied with risks of cardiovascular morbidity and mortality, The tight “glucocentric” approach to the treatment of diabetes by the precedent antidiabetic drugs delivered a setback. This augmented regimen was aborted when it became apparent that it raises the risk of cardiovascular (CV) mortality (as stated by ACCORD-Action to Control CV Risk in diabetes in 2007) [2]. Empagliflozin inhibits the SGLT-2 inhibitor receptors thereby eradicate these effects and concurrently diminishing both preload (by Diuresis) and afterload (by decreasing arteriole stiffness and blood pressure) resulting in considerable reduction in CV mortality [5]. Empagliflozin counters diabetes by inhibiting about 90% of glucose into the blood and excretes it through urine
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