Abstract
Objective: To develop a simple, precise, accurate, method was developed and validated for analysis of metformin hydrochloride (MET) and empagliflozin in (EMPA) in bulk and tablet dosage form.Methods: The method used a reverse phase column, dikma C18 (50×2.1 mm, 1.8 μ), a mobile phase comprising of phosphate buffer (pH-3): methanol (30:70 v/v) flow rate of 1.0 ml/min and a detection wavelength of 240 nm using a photodiode array detector. The proposed method was validated for various parameters like linearity, precision, accuracy, robustness, ruggedness, detection, quantification limits, stability studies, formulation analysis as per International Conference on Harmonization (ICH) guidelines.Results: The retention time was found to be 1.189 min and 1.712 min for MET and EMPA respectively. The proposed method was found to be having linearity in the concentration range of 500-2500 μg/ml for MET (r2=0.989) and 5-25 μg/ml for EMPA (r2=0.994), respectively. The mean % recoveries obtained were found to be 100.35-100.48% for MET and 99.80-101.30% for EMPA respectively. Stress testing which covered acid, base, peroxide, photolytic and thermal degradation was performed on under test to prove the specificity of the method and the degradation was achieved. The developed method has been statistically validated according to International Conference on Harmonization (ICH) guidelines.Conclusion: Thus, the proposed method can be successfully applied for the stability indicating the simultaneous determination of MET and EMPA in bulk and combined tablet dosage form and in the routine quality control analysis.
Highlights
Metformin (MET) hydrochloride is chemically named as (3-(diamino methylidene)-1, 1-dimethylguanidine hydrochloride
metformin hydrochloride (MET) decreases blood glucose levels by decreasing hepatic glucose production, decreasing intestinal absorption of glucose, and improving insulin sensitivity by increasing peripheral glucose uptake and utilization. These effects are mediated by the initial activation by MET of AMP-activated protein kinase, a liver enzyme that plays an important role in insulin signaling, whole body energy balance, and the metabolism of glucose and fats [1,2,3,4,5]
Orthophosphoric acid was obtained from Merck (India), water and methanol for high-pressure liquid chromatography (HPLC) were obtained from lichrosolv (Merck), potassium dihydrogen orthophosphate was obtained from finer chemical Ltd and acetonitrile was obtained from molychem
Summary
Metformin (MET) hydrochloride is chemically named as (3-(diamino methylidene)-1, 1-dimethylguanidine hydrochloride It has a molecular formula of C4H12ClN5 and the molecular weight is 165.62 g/mol. MET decreases blood glucose levels by decreasing hepatic glucose production, decreasing intestinal absorption of glucose, and improving insulin sensitivity by increasing peripheral glucose uptake and utilization. Empagliflozin is an orally administered selective sodium glucose cotransporter-2 (SGLT-2) inhibitor, which lowers blood glucose in people with type 2 diabetes by blocking the reabsorption of glucose in the kidneys and promoting the excretion of excess glucose in the urine [6, 8]. The sodium glucose cotransporter 2 (SGLT2), located in the proximal tubule of the nephron, is estimated to facilitate-90% of this reabsorption [9, 10] It is a potent and selective competitive inhibitor of the SGLT2 protein. In addition to glucose control, SGLT2 inhibitors are associated with weight loss and blood pressure reductions and do not increase the risk of hypoglycemia [9]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
