Development and Validation of Stability Indicating HPTLC Method for the Determination of Metformin Hydrochloride and Benfotiamine in Bulk and Combined Dosage Form

Sakhare, Ram S.; Pekamwar, Sanjay S.; Mohkare, Deepak Prabhakar

doi:10.5530/ijper.51.2s.44

Cited by 10 publications

(1 citation statement)

References 6 publications

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“…The chromatographic conditions for the proposed method were optimized with the help of design expert 11 software. Furthermore, the stability indicating RP-HPLC method was developed for stability 18,19 studies of Ertugliflozin and sitagliptin in different stress conditions to establish inherent stability of the drugs. The method was more validated, and the analysis results were validated statistically and by recovery studies.…”

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confidence: 99%

Untitled

2023

IJPSR

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The concept of quality by design (QbD), which entails understanding the essential components and their interaction effects by a desired set of tests, has lately gained relevance in developing analytical. To validate the simultaneous quantification of Ertugliflozin and Sitagliptin in bulk drugs and its pharmaceutical formulation, the present study discusses the development of the Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method by the QbD methodology employing the Design of Experiments. The three essential elements of the RP-HPLC method-Flow rate (ml/min), Mobile phase (%), and temperature ( o C) are systematically explored in an effective experimental design that is provided. Statistical analysis tools were used to assess the significant impact of these parameters and their interactions with the response variables (Retention time and tailing factor). The 260nm optimized wavelength was chosen. Ertugliflozin and Sitagliptin were shown to have retention times of 3.897 and 2.527 minutes, respectively. Ertugliflozin and Sitagliptin can be estimated simultaneously using a linear method over the ranges of (1.875-11.25 g/ml) and (12.5-75 g/ml), respectively. The correlation coefficient R2 for Ertugliflozin and Sitagliptin are 0.9993 and 0.9995. The method's %RSD for precision and accuracy was discovered to be under 2%. Studies on forced degradation concluded that the strategy indicated stability. Ertugliflozin and Sitagliptin both had %Recovery values of 99.81% and 99.84%, respectively. Retention time and run time decreased, so the method developed was simple and economical and can be adopted in regular Quality control test in Industries. INTRODUCTION:A Quality by Design approach is outlined as a system for planning, analyzing, and dominant manufacturing through timely measurements of essential quality and performance attributes of recent and in-process materials and processes, aiming to ensure the ultimate product safety.

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confidence: 99%

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2023

IJPSR

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One‐Pot Synthesis of Sustainable Fluorescent Nanomaterials via Microwave Irradiation as a Probe for the Determination of Metformin in Pure and Pharmaceutical Dosage Forms: Greenness and Whiteness Metrics

Abou El‐Alamin,

Mohamed,

Farag

2024

Luminescence

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A rapid, green and sensitive technique for the determination of metformin determination was developed based on the direct fluorescence enhancement of carbon dots (CDs) induced by the cited drug. The water‐soluble CDs were prepared via a one‐pot synthesis from avocado peels using domestic microwave. The prepared CDs exhibited strong fluorescence at 405 nm after excitation at 320 nm with a quantum yield of 51%. The fluorescence of CDs was enhanced linearly by increasing the concentration of metformin within the range 0.5–25 μg/mL with limit of detection 0.087 μg/mL and limit of quantification 0.263 μg/mL. The designed probe was proved to be selective toward metformin in the presence of other drugs such as vildagliptin and alogliptin and also in the presence of excipients in the pharmaceutical dosage form. The suggested and reported methods were compared with the help of the whiteness and greenness tools, specifically the white analytical chemistry and analytical greenness metric tools, for assessing hazardous solvents and reagents used.

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