STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF EMPAGLIFLOZIN AND METFORMIN HCl

Patel, Avani

doi:10.20959/wjpps20179-9806

Cited by 7 publications

(4 citation statements)

References 2 publications

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“…[6] Several HPLC methods have been developed for the determination of REM with other drugs such as metformin, teneligliptin hydrobromide hydrate, and vildagliptin. [7][8][9][10] It has been reported that a stability-indicating high-performance thin-layer chromatography approach for REM estimation in tablet formulation has been developed and validated. Studies on forced degradation conducted here reveal that the drug is extremely susceptible to conditions including acid, base, and oxidative stress.…”

Section: Original Articlementioning

confidence: 99%

Untitled

2024

AJP

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Introduction:A reverse phase high-performance liquid chromatography (RP-HPLC) approach that is simple, sensitive, exact, and specific has been developed and verified for Remogliflozin Etabonate (REM) estimation. Materials and Methods: Using an isocratic mode methodology, the RP-HPLC procedure was run on a reversedphase kromasil C18 column (250 mm × 4.6 mm i.d., 5 μm i.d). The detection wavelength was kept at 228 nm and mobile phase consisting of Acetonitrile: 0.1% ortho phosphoric acid in water (60:40). The mobile phase flow rate was maintained at 1 mL/min. For REM, the retention period was 5.5, within the concentration range of 80-120 μg/mL. Results and Discussion: The technique showed linearity with a correlation coefficient (r2) of 0.997. The determined limit of detection and limit of quantitation was 0.186 and 0.563, respectively. In accordance with international conference on harmonization Q2 (R1) guidelines, the suggested approach was verified for linearity, accuracy, precision, and robustness. Studies on forced deterioration were conducted to identify a potential degradation mechanism. There was a noticeable difference in the retention period value between the pure drug peak and the degraded product peak, which could be clearly distinguished. The drug was found to be highly sensitive to acid, base hydrolysis, and peroxide conditions. Degraded products were subjected to mass spectral studies and the m/z values were identified for corresponding degradation products. Conclusion: The created technique can be applied to regular quality control assessments of REM and stability sample analysis.

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Section: Original Articlementioning

confidence: 99%

Untitled

2024

AJP

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“…Various approaches were published in the literature for the simultaneous measurement of CAN and MET utilizing spectrophotometric [13][14][15] and high-performance liquid chromatographic (HPLC) [16][17][18][19][20][21] methods. While, EMP and MET were investigated using spectrophotometric [22][23][24][25][26][27] and chromatographic [20,21,[28][29][30][31][32][33][34][35] methods in pure and pharmaceutical form. Few published researches have discussed the simultaneous determination of the studied drugs with MEL [36][37][38][39][40][41][42].…”

Section: Introductionmentioning

confidence: 99%

Valuation of environmental influence of recently invented high‐performance liquid chromatographic method for hypoglycemic mixtures of gliflozins and metformin in the presence of melamine impurities: Application of molecular modeling simulation approach

Fawzy

Said

2023

J of Separation Science

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Molecular modeling is the science of representing molecular structures numerically and simulating their behavior with the equations of quantum and classical physics. Coupling molecular modeling and simulation with chromatographic resolution for pharmaceutical products constitutes a new technique in pharmaceutical analysis. An innovative high-performance liquid chromatographic (HPLC) methodology was developed for the quantification of metformin hydrochloride (MET), empagliflozin (EMP), and canagliflozin (CAN) in bulk, laboratory-developed combinations, pharmaceutical tablets, and in the presence of melamine. Chromatographic separation was accomplished using a Symmetry column with 0.03 M potassium dihydrogen phosphate buffer and 0.02 M heptane sulphonic acid: acetonitrile as the mobile phase. Molecular modeling using molecular operating environment software was applied to properly select the stationary phase suitable for the developed HPLC method. Additionally, molecular modeling estimates and validates binding between the studied analytes and the stationary phase to clarify and explain the chromatographic separation and elution order. In accordance with the International Conference of Harmonization recommendations, the method was validated in terms of linearity, accuracy, precision, and selectivity. The linearity ranges (μg/ml) were 200-1500 (MET), 2-15 (EMP), and 20-150 (CAN) and the limit of detection values were in the ranges of 0.17-54.58 μg/ml. Analysis of pharmaceutical tablets using the suggested approach yielded satisfactory outcomes. As a result, it might be used in quality control laboratories to analyze the aforementioned medications.

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“…Literature review showed that limited methods of analysis were established for simultaneous determination of the triple combination such as HPLC [ 6 – 8 ], HPTLC[ 6 , 9 ], UPLC [ 10 ] and spectrophotometry [ 11 ],whereas, for their binary combinations, HPLC [ 12 – 14 ], HPTLC [ 15 – 17 ], UPLC [ 17 ], voltammetric method [ 18 ] and spectrophotometric methods were reported [ 19 – 21 ].…”

Section: Introductionmentioning

confidence: 99%

Green and white MEKC for determination of different anti-diabetic binary mixtures and their triple-combo pill

et al. 2023

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The work introduces green and white sustainable micellar electrokinetic chromatography (MEKC) procedure that could analyze therapeutically related drugs, empagliflozin (EMP), linagliptin (LIN) and metformin (MET) which are antidiabetic drugs with different mechanism of action, in their different pharmaceutical combinations. The method not only comply with the green analytical concepts, but also it is in line with sustainable analytical concepts as it is economic by applying the same operating conditions to analyze different pharmaceuticals in quality control (QC) labs which is a crucial step in QC labs and research centers to save time, effort, and money. Moreover, the method functionality regarding its scope with its achieved levels of accuracy, precision, low detection, and quantitation limits is tested using white assessment tool and compared with reported methods. The proposed MEKC coupled with a diode array detector (DAD) has been developed and validated for micro estimation of EMP and LIN in their low critical concentrations with MET in a ratio of (EMP: MET, 1:40) and (LIN: MET, 1:200). Separation was achieved within 6 min using fused silica capillary (40 cm × 50 µm id) using 20 mM Tris buffer (pH 10) in presence of 50 mM sodium dodecyl sulphate and 10% v/v methanol. The concentration ranges of the studied anti-diabetic drugs were 10–500, 10–100 and 2.5–100 µg. mL−1 for MET, EMP and LIN, respectively. The developed method is the first MEKC for concurrent determination of EMP, LIN and MET with high separation efficiency, low solvent consumption and regard as an easy green and white analytical tool. Moreover, Greenness and whiteness assessment were done via the most widely used Analytical Eco-Scale, the innovative AGREE tool and the RGB 12 algorithm.

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STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF EMPAGLIFLOZIN AND METFORMIN HCl

Cited by 7 publications

References 2 publications

Untitled

Untitled

Valuation of environmental influence of recently invented high‐performance liquid chromatographic method for hypoglycemic mixtures of gliflozins and metformin in the presence of melamine impurities: Application of molecular modeling simulation approach

Green and white MEKC for determination of different anti-diabetic binary mixtures and their triple-combo pill

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