Abstract

Aim: The recent analysis is required to do novel and simple, sensitive, precise, efficient, instant and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method for estimation of antidiabetic drug in the unit dosage form. Validation of this method is also planned to make it suitable for the actual use.
 Study Design: Department of Pharmaceutical Chemistry, Datta Meghe Institute of Medical Sciences deemed to be university, Wardha in collaboration with Balkh university, Mazar-e-sharif, Afghanistan between August 2021 and December 2021.
 Methodology: In that article develop the method and validate it by estimation of antidiabetic drugs in solid dosage form by RP-HPLC, by using System suitability test, Repeatability, Precision studies (Intra-day and Interday/Intermediate), Linearity/Calibration studies, Robustness, Force degradation, Specificity, Drug recovery/accuracy studies.
 Results: as per ICH guidelines, the performance if system suitability in remogliflozin were achieved all guidelines; in that, tailing factor (T),separation factors(α),theoretical plates(N),capacity factor (k’), resolution (R) and RSD (%). The validated stress degradation studies under thermal, oxidative, alkali and acid, in few degradation products for remogliflozin (REM).
 Conclusion: From the results we conclude that, this novel technique which validated for exploration by reverse phase high performance liquid chromatography (RP-HPLC) should be used for routine quality control of remogliflozin (REM) prediction from developed formulation.

Highlights

  • According to previous research work, management of glycaemia control and reducing postprandial glucose excursions means change in concentration from before to after a meal can lower the risk of diabetic complications, e.g. Decrease probability of myocardial infarction means decreases or stops to the coronary artery of the heart, renal disease and retinopathy [1,2].the clinical management of T2DM is still difficult to manage, with most of patients failing to reach and maintain their target of glycemic levels in practise [3].Under normal physiological conditions when the glomerular filtrate reaches the proximal tubule, glucose is primarily reabsorbed through the active sodium dependent glucose transporter2 (SGLT2) located on the apical or luminal membrane of the epithelial cell in the S1 segment [4,5,6]

  • SGLT1 and SGLT2 are responsible for the active reabsorption of glucose across the renal luminal membrane [9,10]

  • No any article has been published yet to report the analysis of remogliflozin on C18 column

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Summary

Introduction

According to previous research work, management of glycaemia control and reducing postprandial glucose excursions means change in concentration from before to after a meal can lower the risk of diabetic complications, e.g. Decrease probability of myocardial infarction means decreases or stops to the coronary artery of the heart, renal disease and retinopathy [1,2].the clinical management of T2DM is still difficult to manage, with most of patients failing to reach and maintain their target of glycemic levels in practise [3].Under normal physiological conditions when the glomerular filtrate reaches the proximal tubule, glucose is primarily reabsorbed through the active sodium dependent glucose transporter (SGLT2) located on the apical or luminal membrane of the epithelial cell in the S1 segment [4,5,6]. Genetic alterations in SGLT2 increase renal glucose excretion (upto200g/day) with no apparent adverse effects on renal function or carbohydrate metabolism [11]. Remogliflozin etabonate causes a concentration dependent increase in urinary glucose excretion in mice and rats [12, 13]. Unlike earlier SGLT inhibitors, such as phlorizin and T-1095, remogliflozin displays a high level of selectivity for SGLT2 over SGLT1 [14,15]

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