Experimental Design Approach for Quantitative Expressions of Simultaneous Quantification of Two Binary Formulations Containing Remogliflozin and Gliptins by RP-HPLC

Attimarad, Mahesh; Venugopala, Katharigatta N.; Nair, Anroop B.; Sreeharsha, Nagaraja; Deb, Pran Kishore

doi:10.3390/separations9020023

Cited by 12 publications

(7 citation statements)

References 45 publications

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“…The break at pH = 9.0 is related to the pK a value of VILD; this is due to changes in the protonation-deprotonation equilibrium of the VILD drug. This pK a1 value is very close to the value of VILD in the literature that equal to 9.03 [21,63,64].…”

Section: Study Of the Ph Effectsupporting

confidence: 87%

Voltammetric quantitative analysis of vildagliptin in bulk form and spiked human serum at a modified electrode

et al. 2023

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The electrochemical behavior of Vildagliptin (VILD) was studied using the cyclic voltammetric technique in an aqueous Britton–Robinson (BR) universal buffer solution of various pH levels between 4.0 and 10 at a 5% calcium-montmorillonite clay modified with carbon paste electrode surface (5% Ca-MMT/CPE). The results exhibited an irreversible anodic peak at about 1.238 V versus Ag/AgCl, KCl (3 mol L−1). The anodic peak was found to be diffusion–adsorption controlled. The possible reaction mechanism is estimated taking into consideration of the calculated electrons and protons number transferred on the electrode/electrolyte interface using the cyclic voltammetric technique. VILD was found to adsorb onto the surface of 5% Ca-MMT/CPE in a monolayer surface coverage of 3.0 × 10−12 mol cm−2. A validated square wave voltammetry (SWV) technique for VILD determination was performed. The calibration curve of VILD onto the 5% Ca-MMT/CPE surface was linear in the concentration range of 1.0–110 nmol L−1 with the mean limits of detection and quantification was 0.285 and 0.950 nmol L−1, respectively, in the bulk form. The proposed procedure for the assay of VILD in bulk form, dosage form, and spiked human serum has the advantage of being simple, rapid, sensitive, and inexpensive compared to other analytical methods. The described method showed an excellent performance for the trace determination of VILD in its formulation without interference from excipients. Graphical abstract

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Section: Study Of the Ph Effectsupporting

confidence: 87%

Voltammetric quantitative analysis of vildagliptin in bulk form and spiked human serum at a modified electrode

et al. 2023

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“…A preliminary study showed that using more than 70% acetonitrile in the mobile phase eluted MF after 7 min at a pH less than 5.5, whereas baseline separation between VD and MF was not achieved. Separation quality is important; thus, the typical key response is good resolution between critical analyte peaks [ 56 , 57 , 58 ]. Similar work has been reported on different drugs in which the resolution was the only response, while buffer pH, percentage acetonitrile, and flow rate had a significant effect on the response [ 51 , 52 , 53 , 58 ].…”

Section: Resultsmentioning

confidence: 99%

“…Separation quality is important; thus, the typical key response is good resolution between critical analyte peaks [ 56 , 57 , 58 ]. Similar work has been reported on different drugs in which the resolution was the only response, while buffer pH, percentage acetonitrile, and flow rate had a significant effect on the response [ 51 , 52 , 53 , 58 ]. The three-level face-centered central composite design suggested by the software and the resolution results are tabulated below ( Table 1 ).…”

Section: Resultsmentioning

confidence: 99%

An Experimental Design Approach to Quantitative Expression for Quality Control of a Multicomponent Antidiabetic Formulation by the HILIC Method

et al. 2022

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A rapid and reproducible hydrophilic liquid chromatography (HILIC) process was established for concomitant determination of remogliflozin etabonate (RE), vildagliptin (VD), and metformin (MF) in a formulation. A face-centered central composite experimental design was employed to optimize and predict the chromatographic condition by statistically studying the surface response model and design space with desirability close to one. A HILIC column with a simple mobile phase of acetonitrile (65% v/v) and 20 mM phosphate buffer (35% v/v, pH 6, controlled with orthophosphoric acid) was used to separate RE, VD, and MF. RE, VD, and MF were separated in 3.6 min using an isocratic mode mobile phase flow at a flow rate of 1.4 mL at room temperature, and the analytes were examined by recording the absorption at 210 nm. The developed HILIC method was thoroughly validated for all parameters recommended by ICH, and linearity was observed in the ranges 20–150 µg/mL, 10–75 µg/mL, and 50–750 µg/mL for RE, VD, and MF, respectively, along with excellent regression coefficients (r2 > 0.999). The calculated percentage relative deviation and relative error ascertained the precision and accuracy of the method. The selectivity and accuracy were further confirmed by the high percentage recovery of added standard drugs to the formulation using the standard addition technique. The robustness of the HILIC processes was confirmed by developing a half-normal probability plot and Pareto chart, as the slight variation of a single factor had no significant influence on the assay outcomes. Utilization of the optimized HILIC procedure for concurrent quantification of RE, VD, and MF in solid dosage forms showed accurate and reproducible results. Hence, the fast HILIC method can be regularly employed for the quality assurance of pharmaceutical preparations comprising RE, VD, and MF.

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“…Attimarad et al developed simultaneous quantification of two binary formulations containing remogliflozin and gliptins. 2 Dhara et al developed a UV spectroscopic method for determination of remogliflozin etabonate in bulk and tablet dosage form. 3 Attimarad et al developed multicomponent antidiabetic formulation analysis.…”

Section: Introductionmentioning

confidence: 99%

“…There was only one article available for the content determination using the UV spectroscopy, but this method is not suitable for shelf life analysis due to the lack of stability indicating nature. Attimarad et al developed simultaneous quantification of two binary formulations containing remogliflozin and gliptins . Dhara et al developed a UV spectroscopic method for determination of remogliflozin etabonate in bulk and tablet dosage form .…”

Section: Introductionmentioning

confidence: 99%

Quality by Design Tool Assessed Ultraperformance Liquid Chromatography Method for the Analysis of Remogliflozin and Teneligliptin in Oral Dosage Form

Menda,

Chintala,

Kanuparthy

et al. 2024

ACS Omega

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The UPLC methodology was used to establish a method for determining the qualitative and quantitative content of teneligliptin and remogliflozin tablets in oral solid dose form, as no simultaneous method was available. The developed liquid chromatography method consists of an X-Bridge C18 100 mm × 3.5 mm, 2.1 mm column with an economical 0.2 mL/ min flow rate. A wavelength of 248 nm was used for detection, and the temperature of the column compartment was 30 °C. The method was evaluated using a static tool quality by design after it was validated as per the regulations. The data from validation result in linearity for both analytes with a correlation coefficient of more than 0.999. The accuracy data were found from a minimum of 98.1 to a maximum of 100.9. All of the validation results met the acceptance criteria. The stability of the analytical solutions proved for 24 h at bench and refrigerator temperatures. Studies of force degradation proved the stability indicating the nature of the method. A factorial design was used to evaluate the method performance.

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Experimental Design Approach for Quantitative Expressions of Simultaneous Quantification of Two Binary Formulations Containing Remogliflozin and Gliptins by RP-HPLC

Cited by 12 publications

References 45 publications

Voltammetric quantitative analysis of vildagliptin in bulk form and spiked human serum at a modified electrode

Voltammetric quantitative analysis of vildagliptin in bulk form and spiked human serum at a modified electrode

An Experimental Design Approach to Quantitative Expression for Quality Control of a Multicomponent Antidiabetic Formulation by the HILIC Method

Quality by Design Tool Assessed Ultraperformance Liquid Chromatography Method for the Analysis of Remogliflozin and Teneligliptin in Oral Dosage Form

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