A Validated Stability Indicating Ultra-Performance Liquid Chromatographic Method for Simultaneous Determination of Metformin Hydrochloride and Empagliflozin in Bulk Drug and Tablet Dosage Form

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 (r 2 =0.989) and 5-25 μg/ml for EMPA (r 2 =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.

Malondialdehyde, Adiponectin, Nitric Oxide, C-Reactive Protein, Tumor Necrosis Factor-Alpha and Insulin Resistance Relationships and Inter-Relationships in Type 2 Diabetes Early Stage Is Metformin Alone Adequate in This Stage

“…This indicates hepatocellular damage beginnings as reported before by Toson et al [35]. BUN and uric acid levels were also increased (p<0.05-p<0.001), whereas levels of creatinine were not affected by pre [36].…”

“…The most affected parameter in the diabetic profile was insulin sensitivity; that was increased by 39.4% after treatment. This was expected because it is well-known that metformin acts to improve insulin sensitivity [36]. Metformin exerts its action firstly on the liver to reduce glucose production and, secondly, on the peripheral tissues mainly muscles to augment glucose uptake [37].…”

A a Rapid and Sensitive Rp-HPLC Method for the Quantitative Analysis of Empagliflozin in Bulk and Pharmaceutical Dosage Form

“…Madana et al (2017) divulged that a mobile phase with a concoction of phosphate buffer at pH 3 and methanol in the ratio 30:70 v/v when flushed on a dikma C18 column (50 x 2.1 mm,1.8 µm) an RP-HPLC method was developed for estimation of empagliflozin in the presence of its degradants [9]. Sushil et al (2017) have reported an RP-HPLC method for the quantification of empagliflozin using an Intersil C8 (250 x 4.6 mm x 5 µm) column and a mobile phase comprising of 0.1% orthophosphoric acid and acetonitrile in the ratio 50:50 v/v in gradient elution [10].…”

Development and Validation Stability Indicating HPTLC Method for Determination of Vildagliptin and Metformin Hydrochloride in the Pharmaceutical Dosage Forms

“…The important properties include; high efficacy, safety profile, beneficial cardiovascular and metabolic effects and therapeutic benefit in association with other antidiabetic drugs. Therefore metformin is included in first-line therapy to treat patients with type II diabetes mellitus [2]. In the present study, complimentary actions have drawn in focus to the usage of metal ong with a newer class of antidiabetic drugs, VIL the dipeptidyl peptidase (DPP)-4 inhibitors [1].…”