Stability-indicating capillary electrophoresis method for the simultaneous determination of metformin hydrochloride, saxagliptin hydrochloride, and dapagliflozin in pharmaceutical tablets

Maher, Hadir M.; Abdelrahman, Afnan E.; Alzoman, Nourah Z.; Aljohar, Haya I.

doi:10.1080/10826076.2019.1590208

Cited by 31 publications

(11 citation statements)

References 30 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In addition, the preliminary investigation also showed that phosphate buffer recorded better electropherograms, in terms of resolution, migration time, peak shape, peak height, baseline noise, and the electric current produced, than borate and acetate buffers. The literature also reported that the use of phosphate buffer was appropriate for MET [ 31 , 36 ] and PIO [ 34 ], with other analytes, assay methods.…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Development of Capillary Zone Electrophoresis Method for the Simultaneous Separation and Quantification of Metformin and Pioglitazone in Dosage Forms; and Comparison with HPLC Method

et al. 2023

View full text Add to dashboard Cite

A capillary zone electrophoretic (CZE) method was developed, validated, and applied for the assay of metformin (MET) and pioglitazone (PIO) in pharmaceutical formulations. The optimum running buffer composition was found to be 75 mmol/L phosphate buffer containing 30% acetonitrile (ACN) at pH 4.0. The optimum instrumental conditions were found to be injection time, 10 s; applied voltage, 25 kV; hydrodynamic injection pressure, 0.5 psi for 10 sec, capillary temperature, 25 °C; and the detection wavelength, 210 nm. The quantifications were calculated based on the ratio of the peak areas of analytes to atenolol as an internal standard. The CZE method was validated in terms of accuracy (98.21–104.81%), intra- and inter-day precision of migration time and peak area (relative standard deviation ≤ 5%), linearity (correlation coefficients ≥ 0.9985), limit of detection (≤ 0.277 μg/mL), and limit of quantitation (≤ 0.315 μg/mL). The proposed method was applied for the analysis of PIO and MET both individually and in a combined dosage tablet formulation. All electrophoretic parameters were calculated and evaluated. A previously reported high-performance liquid chromatographic (HPLC) method was also applied to the same samples. A comprehensive comparison was then carried out for the analytical features of both methods CZE and HPLC. Comparable results were obtained with the advantage of reagent consumption and separation efficiency of CZE over HPLC and shorter analysis time by HPLC compared with CZE.

show abstract

Section: Resultsmentioning

confidence: 99%

“…In this context, CZE was exploited for the assay of MET [ 26 , 31 , 32 , 33 ] and PIO [ 34 ] and with other drugs or metabolites. Nevertheless, to our knowledge, no CZE method for the assay of PIO and MET in combination dosage form has been reported.…”

Section: Introductionmentioning

confidence: 99%

Development of Capillary Zone Electrophoresis Method for the Simultaneous Separation and Quantification of Metformin and Pioglitazone in Dosage Forms; and Comparison with HPLC Method

et al. 2023

View full text Add to dashboard Cite

show abstract

“…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

View full text Add to dashboard Cite

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.

show abstract

“…As a result, they are used in combination therapy with other antidiabetic drugs such as MET (Lajara, 2014). The reported methods for analysis of DAPA and MET in combination include UV spectrophotometry (Bhavyasri & Surekha, 2020; Jani et al, 2015), RP‐HPLC (Abbas et al, 2020; Khalil et al, 2018; Urooj et al, 2017), LC–UV (Hassib et al, 2019), LC–MS/MS (Dias et al, 2019; Shah et al, 2019), capillary electrophoresis (Maher et al, 2019) and TLC–spectrodensitometric methods for simultaneous analysis of DAPA and MET (Abdelrahman et al, 2020; Nasser et al, 2018). These methods are less sensitive with several mobile phases and are applied only to pharmaceutical formulations.…”

Section: Introductionmentioning

confidence: 99%

Simple TLC–spectrodensitometric method for studying lipophilicity and quantitative analysis of hypoglycemic drugs in their binary mixture

Abbas

Mohamed

Derayea

et al. 2021

Biomedical Chromatography

View full text Add to dashboard Cite

A selective and simple salting‐out‐assisted thin‐layer chromatographic methodology was developed for the simultaneous determination of two oral hypoglycemic drugs, dapagliflozin (DAPA) and metformin (MET) in their pure forms, tablets and spiked human plasma samples. Silica gel 60 F254 plates were used in the separation of the two drugs using a mobile phase consisting of 0.5 m (NH4)2SO4 and methanol (3:7, v/v). The plates were scanned in the reflectance mode at λmax = 237 nm. The obtained retardation factor (Rf) values for DAPA and MET were 0.77 ± 0.02 and 0.25 ± 0.02, respectively. The thin‐layer chromatography method was validated according to International Conference on Harmonization guidelines. The peak areas were linearly increased with the increases in concentrations of 45–1,000 and 50–1,500 ng/band for DAPA and MET, respectively. Moreover, the method was applied to estimate the molecular lipophilicity parameters of DAPA and MET via retention data. The suggested method was efficiently utilized for the analysis of DAPA and MET in pharmaceutical tablets and plasma samples with recoveries 98.4–100.4 and RSDs in the ranges of 1.4–2.6 and 2.2–3.0% for DAPA and MET, respectively.

show abstract

Stability-indicating capillary electrophoresis method for the simultaneous determination of metformin hydrochloride, saxagliptin hydrochloride, and dapagliflozin in pharmaceutical tablets

Cited by 31 publications

References 30 publications

Development of Capillary Zone Electrophoresis Method for the Simultaneous Separation and Quantification of Metformin and Pioglitazone in Dosage Forms; and Comparison with HPLC Method

Development of Capillary Zone Electrophoresis Method for the Simultaneous Separation and Quantification of Metformin and Pioglitazone in Dosage Forms; and Comparison with HPLC Method

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

Simple TLC–spectrodensitometric method for studying lipophilicity and quantitative analysis of hypoglycemic drugs in their binary mixture

Contact Info

Product

Resources

About