Stability Indicating Simultaneous Estimation of Metformin and Empagliflozin in Pharmaceutical Tablet Dosage form by RP-HPLC

Ali, Syed Irfan; Kumar, Pradeep

doi:10.5958/0974-4150.2017.00131.6

Cited by 10 publications

(3 citation statements)

References 2 publications

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“…Linearity was found in the range of 125-750 ppm, 3.12-18.75 ppm for MET and EMP respectively. The method is validated according to ICH Q2 R1 guidelines 21 .…”

Section: Methodsmentioning

confidence: 99%

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2020

IJPSR

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Diabetes mellitus is a metabolic disorder that causes high levels of blood glucose level in that 90% of the diabetic population accounts for type 2 diabetes mellitus it also has secondary complications like Cardiovascular disorder, Renal impairment, and susceptibility to infections. Empagliflozin is a potentially highly selective Sodium-glucose cotransportace-2 (SGLT-2) inhibitor used for the treatment of type 2 diabetes mellitus alone or in combination with the metformin or dipeptidyl peptidase-4 (DPP-4) inhibitors. The literature entitles the various analytical techniques like UV spectroscopy, High Performance Liquid Chromatography, High Performance Thin Layer Chromatography, Liquid Chromatography-Mass spectrometry. In this literature, we reviewed the various analytical, stability studies, impurity profiling and bio-analytical methods used for the estimation of Empagliflozin. This review gives the concise and collective information about the analytical validating parameters like Limit of detection (LOD), Limit of Quantification (LOQ), Standard Curve, Accuracy & Precision for the analysis of Empagliflozin alone or in combination with the Linagliptin or Metformin. This review helps to carryout further analytical studies on the mentioned drugs. INTRODUCTION: Diabetes mellitus is a chronic metabolic disorder in which the ability of the pancreatic cells to produce or respond to the insulin hormone is decreased. According to WHO, 1.6 million deaths were directly caused and 2.2 million deaths caused due to contraindication with other diseases 1, 2. In type 1, diabetes mellitus, the body's immune system destroys the pancreatic cells that produced insulin. Type 2 diabetes mellitus, which is also referred to as non-insulin-dependent diabetes, accounts for more than 90% of patients with diabetes 3, 4 .

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“…Linearity was found in the range of 125-750 ppm, 3.12-18.75 ppm for MET and EMP respectively. The method is validated according to ICH Q2 R1 guidelines 21 .…”

Section: Methodsmentioning

confidence: 99%

Untitled

2020

IJPSR

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“…A review of the literature shows that there are several methods for the separate determination of metformin HCl and empagliflozin in tablet dosage form by UV spectrophotometer [5][6][7], RP-HPLC [8][9][10][11][12][13][14][15], UPLC [16,17], and some analytical instruments. LC-MS/MS [18].…”

Section: Figure 2 Chemical Structure Of Empagliflozinmentioning

confidence: 99%

A review on method development and validation of stability indicating RP HPLC Method for metformin and Empagliflozin

Vinayak A. katekar,

Prafful P. Kothari,

Swapnil S. Kawarkhe

et al. 2023

GSC Biol. Pharm. Sci.

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Metformin HCl and empagliflozin are oral antidiabetic medications that help control blood sugar levels. A simple, precise, rapid, accurate, sensitive, specific, and stable RP-HPLC method was developed and validated for the simultaneous determination of Metformin and Empagliflozin in drug bulk form and drug dosage. This new RP-HPLC method is superior to formal reversed-phase HPLC with reduced solvent usage, retention time, resolution, and cost. Upper region separation was performed on a Waters HPLC system equipped with a PDA detector and autosampler. Both Metformin and Empagliflozin undergo stress conditions including acid, alkali, oxidative, thermal, and photodegradation, but significant degradation was observed in acid studies. The newly developed RP HPLC chromatographic method was validated for system compatibility, linearity, robustness, accuracy, and precision.

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“…CYG is also known to have an irritant impact on the skin and eyes [14]. AS far as we know, many HPLC methods have been published for the simultaneous measurement of EMP, LIN, and MET mixture alone or in combination with other anti-diabetic medications [15][16][17][18][19][20][21]. The FDA just approved a new combination tablet dosage form, and earlier methods did not work with it.…”

Section: Introductionmentioning

confidence: 99%

HPLC-DAD Technique for the Quantification of A Recently Approved Anti-diabetic Triple Combination Along with Two Toxic Official Impurities: Toxicity Confirmation Aided by Molecular Docking Application

Bahgat

Hashem

Saleh

et al. 2022

Preprint

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Gliflozins and gliptins are two distinct groups of pharmacological drugs that reduce blood glucose levels in individuals with type II diabetes in various ways that may perform their functions harmoniously. Trijardy® tablet, which contains empagliflozin, linagliptin, and metformin, was recently approved. The scientific database does not yet have a method that is sensitive enough to quantify the aforementioned medications in the presence of metformin official toxic impurities melamine and cyanoguanidine. Molecular docking modeling was utilized in this work to further prove the toxicity of melamine. The five analytes listed before were quantified using RP-HPLC-diode array detector and a Zorbax® C8 column (4.6 × 250 mm, 5 μm) with isocratic mobile phase composed of acetonitrile and 0.05 M potassium dihydrogen phosphate buffer, which had been treated by ο-phosphoric acid to restore a pH of 4.0 (90:10, v/v) at a flow rate of 1.2 mL/min and the eluted peaks were scanned at 250 nm. The utilization of the simplest isocratic elution mode give the current technique a significant time-and cost-saving benefit. The current method can quantify the triple therapy agents in the presence of each other as well as with two official toxic impurities of metformin in one short analytical run.

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Stability Indicating Simultaneous Estimation of Metformin and Empagliflozin in Pharmaceutical Tablet Dosage form by RP-HPLC

Cited by 10 publications

References 2 publications

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A review on method development and validation of stability indicating RP HPLC Method for metformin and Empagliflozin

HPLC-DAD Technique for the Quantification of A Recently Approved Anti-diabetic Triple Combination Along with Two Toxic Official Impurities: Toxicity Confirmation Aided by Molecular Docking Application

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