Application of isoindole fluorophore formation for determination of linagliptin in the sole and co-formulated tablets: Application for plasma assay and content uniformity testing

Abu‐hassan, Ahmed A.; Hamd, Mohamed A. El; El-Maghrabey, Mahmoud; Mahdi, Wael A.; Alshehri, Sultan; Mohammed, Bassam Shaaban

doi:10.1016/j.saa.2023.122390

Cited by 11 publications

(13 citation statements)

References 8 publications

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“…It is common practice to use OPA in conjunction with a thiol molecule, such as 2‐ME, to derivatize amino compounds into luminous compounds. A number of medicinal substances have been quantified using this method [36–39]. Previously developed fluorometric methods for STG had disadvantages such as low sensitivity [14, 15] or drastic coupling conditions with high‐cost fluorogenic reagents [13].…”

Section: Resultsmentioning

confidence: 99%

“…Also, compared to an approach that relies on inherent fluorescence monitoring [40], this strategy's LOQ is more sensitive. When 2‐ME is present, the functional amino group in STG allows it to condense with OPA to produce the fluorescent derivative isoindole [36–39]. Figure 1 shows the isoindole fluorescence product monitored at excitation (339.7 nm) and emission (434.6 nm) wavelengths, and Scheme 1 shows the pathway for derivative generation.…”

Section: Resultsmentioning

confidence: 99%

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A new application of isoindole fluorophore derivative in sitagliptin antidiabetic medication assay: Application to dosage forms and biological fluid evaluation

et al. 2023

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Dipeptidyl peptidase-4 enzyme suppressant is a unique category of oral antidiabetic medication. Sitagliptin (STG) is a perfect member of this category and is pharmaceutically marketed alone or in combination with metformin. Here, the ideal application of an isoindole derivative for STG assay was developed using a feasible, easy-to-use, economic, and affordable method. STG as an amino group donor can form a luminescent derivative: isoindole on interaction with o-phthalaldehyde and the existence of (2-mercaptoethanol) 0.02% (v/v) as a thiol group donor. Excitation (339.7 nm) and emission (434.6 nm) wavelengths were used to monitor the isoindole fluorophore yield; moreover, each experimental variable was carefully investigated and adjusted.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

A new application of isoindole fluorophore derivative in sitagliptin antidiabetic medication assay: Application to dosage forms and biological fluid evaluation

et al. 2023

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“…The determination of LNG by spectrofluorometry requires chemical derivatization, as LNG does not naturally have fluorescence. Previous spectrofluorometric derivatization methods have several limitations, including: low sensitivity [6,9,10], which makes them unsuitable for application in biological fluids; the need for alkaline [6][7][8][9] or acidic media [10], which can affect the stability of LNG; long reaction times [8][9][10]; the use of expensive reagents [6,8]; and the use of methanol as a diluting solvent [6,8,10], which is a hazardous chemical.…”

Section: Comparison Between the Current Study And Other Reported Spec...mentioning

confidence: 99%

“…The previously reported spectrofluorometric procedures for determination of LNG suffer from several restrictions, such as low sensitivity [6,9,10], which makes them unsuitable for application in biological fluids, severe derivatization conditions due to heating at the boiling temperature for 20 min [10], the use of expensive reagents such as fluorescamine and 7-chloro-4-nitrobenzo-2-oxa-1,3-diazole (NBD-Cl) [6,8], some of these reported methods require an alkaline pH [6,8,9] or acidic pH [10] as this may affect the stability of the drug and the use of environmentally hazardous reagents such as methanol [6,8,10].…”

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confidence: 99%

Development of sensitive spectrofluorometric approach based on formation of pyrrolidone derivative for determination of linagliptin through condensation reaction with ninhydrin and phenylacetaldehyde: Application to content uniformity and real plasma

El‐Gizawy,

Atia,

Rushdy

et al. 2023

Luminescence

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The new drug linagliptin belongs to the class of dipeptidyl peptidase‐4 enzyme inhibitors. Linagliptin is used to treat type 2 diabetes and is taken orally either alone or in combination with other drugs. In this instance, a new, simple, and economical technique for analyzing linagliptin was developed by the effective use of a pyrrolidone derivative. The primary amine group of linagliptin permits its condensation with ninhydrin (0.14% w/v) to produce a fluorescent product in the presence of phenylacetaldehyde (0.02% v/v). All experimental parameters were carefully examined and adjusted in order to monitor the generation of the pyrrolidone derivative at excitation and emission wavelengths of 385 and 475 nm, respectively. The calibration graph was made by plotting the intensity of the fluorescence in relation to linagliptin concentration. A significant linearity was found for values ranging from 20 to 460 ng/mL. The process's validity has been verified by a thorough assessment of the instructions provided by the International Conference on Harmonization (ICH). The results indicate excellent uniformity with a reference method, showing that there is no substantial difference in precision and accuracy. The proposed approach was utilized for determining linagliptin in real rat plasma successfully owing to its high sensitivity. Additionally, the proposed approach was evaluated using the Eco‐Scale evaluation tool and showed a high degree of eco‐friendliness (86/100).

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“…Spectrofluorimetry is a very important analytical technique due to its low cost, high selectivity and sensitivity that allow easy quantitative analysis of a lot of pharmaceutical compounds [1][2][3][4][5][6]. Despite all these great features, it is not useful in the cases of concurrent determination of two drugs that have overlapped emission spectra.…”

Section: Introductionmentioning

confidence: 99%

Green Constant-wavelength Concurrent Selective Fluorescence Method for Assay of Ibuprofen and Chlorzoxazone in Presence of Chlorzoxazone Degradation Product

et al. 2023

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Lower back pain is a universal dilemma leaving a negative effect on both health and life quality. It was found that a fixed dose combination of chlorzoxazone and ibuprofen gave a higher efficiency than analgesic alone in treatment of acute lower back pain. Based on the significant benefit of that combination, a green, sensitive, rapid, direct, and cost-effective method is created for concurrent determination of ibuprofen and chlorzoxazone in presence of 2-amino para chlorophenol (a synthetic precursor and potential impurity of chlorzoxazone) adopting the synchronous spectrofluorimetric technique. Synchronous spectrofluorimetric technique is adopted to avoid the highly overlapped native spectra of both drugs. The synchronous spectrofluorometric method was applied at Δλ = 50 nm, ibuprofen was measured at 227 nm while chlorzoxazone was measured at 282 nm with no hindering from one to another. The various experimental variables affecting the performance of the suggested technique were explored and adjusted. The suggested technique showed good linearity from 0.02 to 0.6 and 0.1 to 5.0 µg/mL for ibuprofen and chlorzoxazone, respectively. The produced detection limits were 0.27 × 10–3 and 0.03, while the quantitation limits were 0.82 × 10–3 and 0.09 µg/mL for ibuprofen and chlorzoxazone, respectively. The suggested approach was successfully applied for the analysis of the studied drugs in the synthetic mixture, different pharmaceutical preparations, and spiked human plasma. The suggested technique was validated with respect to the International Council of Harmonization (ICH) recommendations. The suggested technique was found to be simpler and greener with lower cost compared to the earlier reported methods which required complicated techniques, longer time of analysis, and less safe solvents and reagents. Green profile assessment for the developed method compared with the reported spectrofluorometric method was performed using four assessment tools. These tools confirmed that the recommended technique attained the most possible green parameters, so it could be used as a greener option in routine quality control for analyzing the two drugs in genuine form and pharmaceutical preparations.

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Application of isoindole fluorophore formation for determination of linagliptin in the sole and co-formulated tablets: Application for plasma assay and content uniformity testing

Cited by 11 publications

References 8 publications

A new application of isoindole fluorophore derivative in sitagliptin antidiabetic medication assay: Application to dosage forms and biological fluid evaluation

A new application of isoindole fluorophore derivative in sitagliptin antidiabetic medication assay: Application to dosage forms and biological fluid evaluation

Development of sensitive spectrofluorometric approach based on formation of pyrrolidone derivative for determination of linagliptin through condensation reaction with ninhydrin and phenylacetaldehyde: Application to content uniformity and real plasma

Green Constant-wavelength Concurrent Selective Fluorescence Method for Assay of Ibuprofen and Chlorzoxazone in Presence of Chlorzoxazone Degradation Product

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