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The result of pharmaceutical industry research for the new class and the new combination of drugs for the treatments of diabetes is the newly approved combination of metformin (MET) and remogliflozin (REM). For the quality control of this formulation, three smart, reproducible and non-sophisticated spectroscopic techniques were developed by modific...
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... HCl, chemically known as 1,1-Dimethylbiguanide hydrochloride ( Figure 1A) is extensively used for the management of diabetes mellitus Type-2. It is a first choice for the management of blood glucose due to its multiple mechanisms of action and safety. ...
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... Several SGLT inhibitors such as canagliflozin, empagliflozin dapagliflozin are successfully administered with metformin. 6 Recently, Food and Drug Administration has approved a combination of remogliflozin etabonate ( Figure 1B) and metformin filmcoated tablets in two strengths of 500 mg / 1000 mg MET with 100 mg REM. 7 REM chemically known as β-D-Glucopyranoside, 5-methyl-4-[[4-(1-methylethoxy)phenyl]methyl]-1-(1-methylethyl)-1H-pyrazol-3-yl, 6-(ethyl carbonate), acts by inhibiting specific enzyme SGLT-2 and is insulinindependent anti-diabetic drug. ...
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... HCl, chemically known as 1,1-Dimethylbiguanide hydrochloride ( Figure 1A) is extensively used for the management of diabetes mellitus Type-2. It is a first choice for the management of blood glucose due to its multiple mechanisms of action and safety. ...
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... Several SGLT inhibitors such as canagliflozin, empagliflozin dapagliflozin are successfully administered with metformin. 6 Recently, Food and Drug Administration has approved a combination of remogliflozin etabonate ( Figure 1B) and metformin filmcoated tablets in two strengths of 500 mg / 1000 mg MET with 100 mg REM. 7 REM chemically known as β-D-Glucopyranoside, 5-methyl-4-[[4-(1-methylethoxy)phenyl]methyl]-1-(1-methylethyl)-1H-pyrazol-3-yl, 6-(ethyl carbonate), acts by inhibiting specific enzyme SGLT-2 and is insulinindependent anti-diabetic drug. ...
Citations
... The literature survey found that for this triple drug formulation, no forced degradation study was performed. [4][5][6][7][8][9][10][11][12][13][14] So, the present research aimed to develop a stability indicating reverse phase liquid chromatographic method for the simultaneous determination of MET, VIL and REM in bulk and drug formulation suitable for routine analysis. ...
A simple and efficient stability-indicating method has been developed and validated for the simultaneous estimation of vildagliptin, metformin hydrochloride and remogliflozin etabonate in bulk and was applied on marketed formulations. KH2PO4 buffer (10 mM): Acetonitrile (70:30% v/v) at pH 5 was used as a mobile phase. Detection of drug peaks was at 215 nm by UV detector. The method was found to be linear in the concentration range of 2.5 to 7.5, 25 to 75 and 5 to 15 μg/mL for vildagliptin, metformin hydrochloride and remogliflozin etabonate, respectively. The limit of detection (LoD) and quantitation (LoQ) were found to be 0.137 and 0.415 μg/mL for vildagliptin, 3.737 and 11.326 μg/mL for metformin hydrochloride and 0.348 and 1.055 μg/mL for remogliflozin etabonate. Hydrolysis by HCl, NaOH, hydrogen peroxide, UV light and temperature were performed on a formulation which proves that the proposed method was specific
... The literature review summarized as UV spectroscopic, chromatographic and densitometric methods for the determination of RGE in tablet matrix for single dose and fixed dose formulations. [9][10][11][12][13][14][15][16][17][18] The spectroscopic and chromatographic methods for VLG were reported. [19][20][21][22] Spectroscopic methods and chromatographic methods were reported for the estimation of MFH in single and fixed dose combinations. ...
... [19][20][21][22] Spectroscopic methods and chromatographic methods were reported for the estimation of MFH in single and fixed dose combinations. [8,[11][12][13][23][24][25][26][27][28][29] Hyphenated techniques were also reported for RGE, VLD and MFH. [30][31][32][33][34] Recently two chromatographic methods, one HILIC and another HPLC methods were reported for the concurrent determination of RGE, VLD and MFH but both the reported methods utilized more organic solvents. ...
... One HPLC method, has been reported for REM in combination with teneligliptin [23]. There are few methods comprising of HPTLC, UHPLC, UPLC, HPLC and UV methods have been reported for REM in combination with MET [24][25][26][27][28][29][30], but no method reported for REM with MET by UFLC. Every laboratory requires an analysis technique to evaluate the formulation's content precise and accurately. ...
An advanced formulation having remogliflozin etabonate (REM) and metformin hydrochloride (MET) for the treatment of diabetes was
recently approved. However, there hasn't been any information reported on a UFLC technique for simultaneously quantifying both active
substances. Therefore, aim of the study was the development of an ultra-fast isocratic liquid chromatography method for quantification of
MET and REM in API and dosage form. The reversed phase-UFLC method was developed with a very short run time of only 3 min with no
interference due to blank. The compounds were separated using Shimadzu Sim-pack XR ODS (75 mm × 3 mm, 2.2 μ) column with mobile
phase consisting of buffer (0.1% phosphoric acid):acetonitrile (30:70). The developed method was validated as per ICH-Q2(R1). The linearity
was established in the range of 0.01-125 ppm and 0.01-25 ppm for MET and REM, respectively. The average assay was found 99.4% for
MET and 99.1% for REM. The accuracy was observed 98.29-99.49% for MET and 98.39-99.73% for REM. The proposed method is very
fast and simple however precise and accurate. This method is very useful for regular quality control laboratory to quantify MET and REM in
API and dosages forms.
... Although there are many reports was published for regular Quality control checking of REMO combination with MET in both alone and formulation dosage forms using UPLC/PDA detection [11]. Utilization of full factorial Box-Behnken design model developed RP-HPLC and Green Second-Derivative UV Spectroscopic Method [12,13]. For Greenness Evaluation established Eco-friendly manipulated UV spectroscopic techniques, semi-quantitative and quantitative methods and the employments of modification of UV spectra, three smart, reproducible and non-sophisticated spectroscopic techniques were developed [14]. ...
Objective: Remogliflozin (REMO), a selective inhibitor of the renal sodium-dependent glucose transporter 2 channel, which could increase urine glucose excretion and lower plasma glucose in humans. To establish a simple, sensitive and completely validated HPLC-MS-MS approach for the analysis of Remogliflozin in rat plasma samples. Methods: The method was developed after simple step protein precipitation by acetonitrile and Empagliflozin (EMPA) was used as internal standard. Separation was done on an CORTECS C18, 90 Å, 2.7 µm, 4.6 mm X 150 mm with an isocratic mobile phase consisting of 0.1% Formic acid: acetonitrile (20:80%, v/v) and pumped at a flow stream of 0.8 ml/min at ambient temperature. Results: The approach developed showed fine calibration curve in the quantity range of 5-1000 pg/ml with correlation coefficient (r2) of ≥ 0.9997 and the intra-run accuracy and precision was 99.91 to 109.07% and 0.17 to 1.34, inter-run accuracy and precision was 99.8 to 101.54 and 0.17 to 1.66 according to FDA guidelines. Conclusion: The newly designed and validated approach was simple, fast and applied effectively for single-dose oral pharmacokinetic investigation in Wistar male rats for the quantification of REMO in biological matrix.
The result of pharmaceutical industry research for the new class and the new combination of drugs for the treatments of diabetes is the newly approved combination of Remogliflozin etabonate (RGE) and Teneligliptin Hydrobromide hydrate (TG). For the quality control of this formulation, the smart, reproducible and non-sophisticated spectroscopic techniques were developed by modification of UV spectra. The proposed methods exhibited Beer’s law in the range of 10 to 60µg/ml and 5 to 30µg/ml for RGE and TG correspondingly. The mean percentage recovery was found to be in the range of 98.60 to 101.55 for RGE and 99.87 to 100.21 for TG. Further, both analytes were quantified from the formulation using proposed spectroscopic methods with high accuracy. The suggested technique is simple, accurate and reproducible, hence could be used for regular quality control of formulation consisting of RGE and TG. The developed method can be used for analysis of stability samples and routing quality control evaluation in tablet formulation.
A recently approved FDC of Remogliflozin Etabonate (100mg) and Teneligliptin Hydrobromide Hydrate (10mg) recommended to treat type II diabetes. There is no any reported analytical methods available for simultaneous quantification of Remogliflozin Etabonate and Teneligliptin Hydrobromide Hydrate. Thus, the objective for this literature survey was to gather information on various analytical instrumental methods used so far for the individual quantitation of Remogliflozin Etabonate and Teneligliptin Hydrobromide Hydrate in various matrices. The reported methods are high performance liquid chromatography, hyphenated techniques, spectroscopy and high performance thin layer chromatography or thin layer chromatography for Remogliflozin Etabonate and Teneligliptin Hydrobromide Hydrate respectively. This review outlines the recent position of method development and validation of newly approved fix dose combination of Remogliflozin Etabonate and Teneligliptin Hydrobromide Hydrate in bulk, solid dosage form and synthetic mixture.
Garlic (Allium sativum) is an herb used widely as a flavoring in cooking has also been used as a medicine throughout ancient and modern history to prevent and treat wide range of conditions and diseases. It is found that Garlic is one of the most known traditional herbal remedy for a wide range of ailments. It's used to improve blood circulation to reduce the risk of heart disease. Garlic also thought to help reduce high cholesterol and elevated blood pressure. Antioxidants help to contains and remove those harm full substances before they can accumulate and damage the body. The oils that extracted from the species and herbs are found to be effective in killing bacteria, viruses and others. Garlic is used for many conditions related to heart and blood system these conditions include high blood pressure, high cholesterol coronary heart disease and hardening of arteries.
Introduction: A new, simple, precise, accurate, and reproducible method was developed and validated for the simultaneous estimation of Metformin Hydrochloride (MH) and Pravastatin Sodium (PS) in pure form. Methodology: Simultaneous estimation of Metformin Hydrochloride (MH) and Pravastatin Sodium (PS) was estimated by ultraviolet (UV) spectrophotometry using the absorbance subtraction method. The method was based on the measurement of absorbance at two wavelengths 232 nm and 238 nm, of metformin and Pravastatin Sodium respectively. These studies were performed at three different levels (75%, 100%, and 125%) and the % recovery of MH and PS was calculated. Results: The LOD and LOQ were found to be 0.481 μg/ml and 0.670μg/ml for MH and 1.15μg/ml and 1.68μg/ml for PS respectively. All the statically analyses were within the standard limits. It proves that the method was repeatable and selective for the simultaneous. Conclusion: Therefore, the present study concludes that it can be successfully used for simultaneous estimation of MH and PS in pure and pharmaceutical dosage forms. The developed method was found to be simple, precise, and accurate.
