Novel UV Spectroscopic Methods for Simultaneous Assessment of Empagliflozin, Linagliptin and Metformin in Ternary Mixture

Sen, Ashim Kumar; Pandey, Harshita; Maheshwari, Rajesh; Zanwar, Aarti Sachin; Velmurugan, Ramaswamy; Sen, Dhanya B.

doi:10.5530/ijper.56.4s.213

Cited by 9 publications

(7 citation statements)

References 38 publications

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“…The projected approaches were authenticated using the regulations of the "International Conference on Harmonization". 28,37,[39][40][41][43][44][45][46][47][48]…”

Section: Validation Of Spectroscopic Methodsmentioning

confidence: 99%

New Eco-friendly UV-spectroscopic Methods for Simultaneous Assessment of Dapagliflozin, Saxagliptin and Metformin in Ternary Mixture

Sen¹,

Jatu²,

Maheshwari³

et al. 2023

Ind. J. Pharm. Edu. Res.

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Background and Aim: Qternmet XR ® consisting of dapagliflozin (10 mg), saxagliptin (5 mg), and metformin hydrochloride (1000 mg), is a fixed-dose combination (tablets) that improves glycemic control in individuals with diabetes mellitus (type 2). The projected work presents four spectrophotometric methods that are eco-friendly, quick, effortless, accurate and reproducible for the concurrent assessment of the ternary mixture. Materials and Methods: The 1 st approach works on the notion of unravelling pre-existing equations (simultaneous) by measuring absorbance at 223, 212 and 232.6 nm for dapagliflozin, saxagliptin and metformin hydrochloride, sequentially. The second method namely ratio difference spectroscopy works by evaluating the variation in amplitude at two dissimilar wavelengths in the ratio spectra. Whereas the derivative ratio spectrum zero-crossing approach (third approach) relied on the utilization of the derivative ratio signals at zero-crossing locations. The fourth approach is the double divisor-ratio spectra derivative approach in which the first derivative of ratio spectrum was acquired and the concentrations of all 3 drugs in their combination were quantified. Results and Discussion: All the three drugs exhibited excellent linear correlation in the concentration series of 2-10 µg/mL for simultaneous equation method and 0.5-10 µg/mL for all the other methods with an exceptional correlation coefficient value. Furthermore, the projected approaches were authenticated in line with ICH strategies and which displayed suitable precision, accuracy and sensitivity. Conclusion:The developed spectrophotometric approaches when compared to other analytical procedures are regarded to be more cost-effective because they do not require expensive solvents or sophisticated instruments. Therefore, the projected methods could be effectively employed for the concurrent assessment of dapagliflozin, saxagliptin and metformin hydrochloride in ternary mixture.

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“…The projected approaches were authenticated using the regulations of the "International Conference on Harmonization". 28,37,[39][40][41][43][44][45][46][47][48]…”

Section: Validation Of Spectroscopic Methodsmentioning

confidence: 99%

New Eco-friendly UV-spectroscopic Methods for Simultaneous Assessment of Dapagliflozin, Saxagliptin and Metformin in Ternary Mixture

Sen¹,

Jatu²,

Maheshwari³

et al. 2023

Ind. J. Pharm. Edu. Res.

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show abstract

“…The established methodologies were validated as given in the recommendations of the "International Conference on Harmonization. " 12,37,38,42,[47][48][49]…”

Section: Validation Of Spectroscopic Approachesmentioning

confidence: 99%

Different Innovative UV-spectroscopic Approaches for Simultaneous Assessment of Celecoxib and Tramadol Hydrochloride in Binary Mixture

Sen,

Darji,

Sen

et al. 2023

Ind. J. Pharm. Edu. Res.

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Background and Aim: Tablets containing celecoxib and tramadol hydrochloride that are sold under the brand name Seglentis® have given approval by the "Food and Drug Administration" (FDA) for the treatment of adults suffering from acute pain. Simultaneous assessment of celecoxib and tramadol hydrochloride in synthetic mixture was performed by five new UV-spectrophotometric approaches. Materials and Methods: The quantification of proposed medication was performed using the simultaneous equation approach by measuring absorbance at 217.2 and 272.4 nm. The second approach, known as the dual wavelength method, relies on computing the absorbance difference at two different wavelengths where the other drug has same absorbance. The first derivative zero crossing approach relied on the conversion of UV-spectra into first derivative spectra and subsequently measuring the amplitude at 272.4 and 229.6 nm for celecoxib and tramadol hydrochloride, respectively. The ratio difference approach was used to measure the variation in the amplitudes of ratio spectra, and the regression equation was employed to determine the amounts of pharmaceuticals. In first derivative ratio spectra approach, the UV-spectra were transformed into their ratio spectra and first derivatives, and the first-derivative signal was gauged at 236.4 and 229.8 nm for celecoxib and tramadol hydrochloride, sequentially. Results and Discussion: All the parameters were evaluated during validation of the new methods in accordance with ICH guidelines. For both medicines, a linear response was observed in all five methods over the concentration series of 1-18 µg/mL. Method validation parameters were found to be within the permitted limits set forth by the ICH. Conclusion: Assay results were compared using Repeated Measures ANOVA, IBM SPSS, version 20.0. The findings of the statistical analysis demonstrated that none of the projected methods differed significantly from others. Thus, the anticipated approaches have the potential to be productively utilized for the simultaneous evaluation of celecoxib and tramadol hydrochloride in a combination mixture.

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“…People with diabetes usually need a combination of medications to manage their blood glucose levels effectively [6]. In the later part of 2022, a new combination of DPZ and VGT was introduced to the Indian market.…”

Section: Introductionmentioning

confidence: 99%

“…This fixed‐dose combination (FDC) is available in tablet form (sustained release), containing DPZ (10 mg) and VGT (100 mg). The FDC tablets are designed to benefit individuals with type 2 diabetes in maintaining their blood sugar concentrations effectively [6–9].…”

Section: Introductionmentioning

confidence: 99%

“…UV spectrophotometry [10–14], HPLC [3, 15–20], and high‐performance thin layer chromatography (HPTLC) [21–25] are among the analytical approaches stated in the literature for quantifying the concentrations of DPZ and VGT, either separately or in blend with other substances, in bulk drug samples or pharmaceutical formulations. Among the various methods reported, Attimarad et al.…”

Section: Introductionmentioning

confidence: 99%

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Development and validation of high‐performance thin layer chromatographic method for concurrent estimation of dapagliflozin and vildagliptin in combined tablet

Sen,

Khatariya,

Sen

et al. 2023

Separation Science Plus

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Enhanced glycemic regulation in individuals with diabetes mellitus can be achieved using a fixed‐dose combination of dapagliflozin (10 mg) and vildagliptin (100 mg) in tablet. The primary objective of this research was to develop and validate a high‐performance thin layer chromatographic methodology for accurately measuring the quantities of dapagliflozin and vildagliptin in combined tablet formulation. The methodology involved using aluminum plates layered with silica gel 60F254, and the solvent system comprised of acetonitrile, benzene, and glacial acetic acid (9:1:2 v/v/v). Densitograms were scanned at a wavelength of 210 nm. The linearity of the procedure was established in the series of 200–2500 ng/band for dapagliflozin and 2000–25000 ng/band for vildagliptin, with correlation coefficients (r2) of 0.9931 and 0.9954, correspondingly. The method demonstrated good sensitivity, with detection limits of 21.07 ng/band for dapagliflozin and 154.97 ng/band for vildagliptin; quantification limits of 63.84 ng/band for dapagliflozin and 469.60 ng/band for vildagliptin. The methodology was found to be precise (% relative standard deviation of peak area <2) and accurate (recovery between 97% and 103%). Proposed method was found to be superior and capable of overcoming the shortcomings of previously reported methods for the assessment of dapagliflozin and vildagliptin in combined formulation.

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Novel UV Spectroscopic Methods for Simultaneous Assessment of Empagliflozin, Linagliptin and Metformin in Ternary Mixture

Cited by 9 publications

References 38 publications

New Eco-friendly UV-spectroscopic Methods for Simultaneous Assessment of Dapagliflozin, Saxagliptin and Metformin in Ternary Mixture

New Eco-friendly UV-spectroscopic Methods for Simultaneous Assessment of Dapagliflozin, Saxagliptin and Metformin in Ternary Mixture

Different Innovative UV-spectroscopic Approaches for Simultaneous Assessment of Celecoxib and Tramadol Hydrochloride in Binary Mixture

Development and validation of high‐performance thin layer chromatographic method for concurrent estimation of dapagliflozin and vildagliptin in combined tablet

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