Fluorescence spectroscopy for determination of dapagliflozin in pure form and its tablets formulation; Application to content uniformity testing

Omar, Mahmoud A.; Ahmed, Hytham M.; Batakoushy, Hany A.; Hamid, Mohamed A. Abdel

doi:10.1016/j.saa.2020.118642

Cited by 6 publications

(4 citation statements)

References 7 publications

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“…Few researchers studied its pharmacokinetics in biological fluids by selecting Bioanalytical methods [11][12][13] and there are some other methods reported like HPTLC, Fluorescence and capillary electrophoresis for estimation of Dapagliflozin, in combination with other anti-diabetic agents like Saxagliptin/Metformin [14][15][16].…”

Section: Fig 1: Chemical Structure Of Dapagliflozinmentioning

confidence: 99%

Simple Quantified and Validated Stability Indicating Stress Degradation Studies of Oral Anti-Diabetic Agent Dapagliflozin by Rp-HPLC Method

Murugesan¹,

Annapurna

2022

Int J App Pharm

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Objective: This method is focused on developing a precisely simplified and more accurate Reverse Phase–High Pressure Liquid Chromatography (RP-HPLC) method for the determination of Dapagliflozin in bulk and pharmaceutical dosage form as per guidelines of International Council for Harmonization (ICH). Methods: Evaluation and validation carried out using the RP-HPLC ZORBAX (C18) column (250 x 4.6 mm, 5 μm particle size) with a mobile phase consisting of Phosphate Buffer: Acetonitrile: Methanol in a ratio of 55:40:05 (v/v/v) at a flow rate of 1 ml/min with an injection volume of 10 μl. Results: Dapagliflozin was eluted at 2.12±0.05 min and detected at 225 nm. The regression equation y = 55762 x-29679 found to be linear with correlation coefficient r2 value of 0.9997. The developed RP-HPLC method was conveniently validated as per the ICH guidelines and found method was robust, sensitive, accurate, selective, specific, precise and linear. Conclusion: The proposed method was found to be accurate, precise, and robust for API and pharmaceutical dosage form as per experimentation analysis. The above developed method was found to be satisfied for Active Pharmaceutical Ingredient (API) and pharmaceutical formulation of Dapagliflozin to study its degradation products.

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Section: Fig 1: Chemical Structure Of Dapagliflozinmentioning

confidence: 99%

Simple Quantified and Validated Stability Indicating Stress Degradation Studies of Oral Anti-Diabetic Agent Dapagliflozin by Rp-HPLC Method

Murugesan¹,

Annapurna

2022

Int J App Pharm

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“…In the field of material science, a candidate analytical method, namely spectrofluorimetry, has become a common base for many sensitive determinations 12 – 15 . Its intrinsic sensitivity, rapidity, and wide linear range of detections make the utility of spectrofluorimetry desirable for routine analysis and monitoring 16 .…”

Section: Introductionmentioning

confidence: 99%

Application of quality-by-design for adopting an environmentally green fluorogenic determination of benoxinate hydrochloride in eye drops and artificial aqueous humour

Hamd

El-Maghrabey

Magdy

et al. 2023

Sci Rep

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Herein, a sensitive and selective spectrofluorimetric method has been developed for the determination of the ocular local anesthetic benoxinate hydrochloride (BEN-HCl) in eye drops and artificial aqueous humour. The proposed method is based on the interaction of fluorescamine with the primary amino group of BEN-HCl at room temperature. Following the excitation of the reaction product at 393 nm, the emitted relative fluorescence intensity (RFI) was measured at 483 nm. The key experimental parameters were carefully examined and optimized by adopting an analytical quality-by-design approach. The method used a two-level full factorial design (24 FFD) to obtain the optimum RFI of the reaction product. The calibration curve was linear at the range of 0.10–1.0 μg/mL of BEN-HCl with sensitivity down to 0.015 μg/mL. The method was applied for analyzing the BEN-HCl eye drops and could also assess its spiked levels in artificial aqueous humour with high % recoveries (98.74–101.37%) and low SD values (≤ 1.11). To investigate the green profile of the proposed method, a greenness assessment was performed with the aid of the Analytical Eco-Scale Assessment (ESA) and GAPI. The developed method obtained a very high ESA rating score in addition to being sensitive, affordable, and environmentally sustainable. The proposed method was validated according to ICH guidelines.

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“…Also, the reported electrochemical methods always need electrode pre-modification. Thus, we found it urgent to establish a simple and time-saving approach for NTZ determination [19][20][21][22][23][24]. Fluorimetry is a sensitive and relatively selective approach that has been applied for NTZ analysis.…”

Section: Introductionmentioning

confidence: 99%

A Turn-On–Type Fluorescence Resonance Energy Transfer Eco-friendly Method for Nitazoxanide Quantification in Pharmaceutical Dosage Form and Spiked Plasma: Evaluation of Greenness Profile Using Different Assessment Tools

et al. 2022

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A brand-new class of anti-infective drugs that work against bacteria, viruses, and protozoan parasites is nitazoxanide and related thiazolides. Thiazolides have also been shown to cause cell cycle arrest and apoptotic cell death in cancer cells in recent years. In this study, an eco-friendly, spectrofluorimetric technique that is verified, easy, and sensitive has been proposed for quantifying nitazoxanide (NTZ), a broad-spectrum antiparasitic drug. When NTZ is reduced with zinc (Zn) powder in an acidic media, a highly fluorescent product is produced. To get the highest sensitivity, different experimental conditions impacting the response were examined and optimized. Following excitation at 299 nm, scanning of the fluorescent product was done at 440 nm. The intensity of the fluorescence was proportional to the drug concentration in the range of 0.1–0.6 μg/mL. The approach was validated according to International Conference on Harmonization (ICH) guidelines, and the outcome was satisfactory. The detection and quantitation limits were calculated to be 0.013 and 0.038 μg/mL, respectively. The suggested technique was successful in analyzing commercially available NTZ dosage forms. Furthermore, the proposed technique was used to assess NTZ levels in human plasma and it was bio-analytically validated according to European Medicines Agency (EMA) guidelines. The suggested method can be used in quality control laboratories as well as in pharmacokinetic studies. In order to picture the green profile of the developed method, four greenness assessment tools have been applied. National Environmental Methods Index (NEMI), analytical Eco-Scale Assessment (ESA), Green Analytical Procedure Index (GAPI) and Analytical Greenness metric (AGREE) are the relatively most widely used metrics. So, they were utilized to perform a detailed greenness comparison between the proposed method and some of the reported methods for the determination of NTZ. The developed method was found to be an excellent green method with the highest AGREE score.

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Fluorescence spectroscopy for determination of dapagliflozin in pure form and its tablets formulation; Application to content uniformity testing

Cited by 6 publications

References 7 publications

Simple Quantified and Validated Stability Indicating Stress Degradation Studies of Oral Anti-Diabetic Agent Dapagliflozin by Rp-HPLC Method

Simple Quantified and Validated Stability Indicating Stress Degradation Studies of Oral Anti-Diabetic Agent Dapagliflozin by Rp-HPLC Method

Application of quality-by-design for adopting an environmentally green fluorogenic determination of benoxinate hydrochloride in eye drops and artificial aqueous humour

A Turn-On–Type Fluorescence Resonance Energy Transfer Eco-friendly Method for Nitazoxanide Quantification in Pharmaceutical Dosage Form and Spiked Plasma: Evaluation of Greenness Profile Using Different Assessment Tools

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