Utility of a fluorescent probing strategy for designing a distinctive chemically mutagenized reaction for the determination of an antiepileptic agent; topiramate

Применение флуоресцентного зондирования для разработки специфической химически мутагенной реакции для определения противоэпилептического препарата топирамата
Ahmed Abdulhafez Hamad
2022-12-19

Topiramatefluorescent probingfluorometric assayninhydrin reagentphenylacetaldehyde
In many experimental applications, fluorescent probes (fluorophores or just fluors) have replaced more traditional methods because of their adaptability, sensitivity, and quantifiability. The target analyte molecule (Topiramate) does not include any fluorogenic or chromophoric groups; hence it has no fluorescence in its native state or light absorptive power when exposed to ultraviolet light, thus; it is impossible to analyze it directly and must be undergone chemical mutagenicity in its molecular structure. This phenomenon can be achieved through fluorescent probing or labeling with tagging reagent. Consequently, the current analytical methodology depends on the fluorescence probe development via the ninhydrin reagent's utility to birth a condensed fluorescent derivative that can be tracked fluorimetrically. The final product was monitored at λem 482 nm after excitation at λex 381 nm. Under appropriate conditions, topiramate's primary amine group can condense with ninhydrin (β-diketone) and phenylacetaldehyde in a buffered solution. A new, green, feasible, and selective fluorometric strategy for topiramate assay has been presented in this work. The method offers linearity at a topiramate concentration range of 0.5 – 8 μg mL−1. The method's quantum yield was rated, and the validation parameters were examined following the International Council for Harmonisation (ICH) rules. Finally, the proposed probe was efficiently employed in the topiramate testing in the batched powder and available dosage form with high accuracy, and there was no significant effect with the existence of excipients. The findings indicate an impressive alignment with the reference documented method, showing no major variations in precision and accuracy.
1
A fluorescent probing strategy using ninhydrin and phenylacetaldehyde produces a condensed fluorescent derivative of topiramate measurable at λex 381 nm and λem 482 nm.
2
Application to bulk powder and commercial dosage forms showed no significant interference from excipients and good agreement with a reference method.
3
The developed green, feasible, and selective fluorometric method is linear over 0.5–8 μg mL−1 topiramate.
4
The method's quantum yield was determined and validation followed ICH guidelines, demonstrating high accuracy and precision.
5
Topiramate lacks native fluorogenic or chromophoric groups and cannot be directly analyzed by fluorescence or UV methods.
6
Under buffered conditions, topiramate's primary amine condenses with ninhydrin (β-diketone) and phenylacetaldehyde enabling the fluorometric assay.

Topiramate chemically derivatized with a ninhydrin/phenylacetaldehyde fluorescent probe in buffered solution

Development and validation of a selective fluorometric assay—formation, fluorescence properties (λex 381 nm, λem 482 nm, quantum yield), linearity (0.5–8 μg·mL−1), accuracy, and precision—of the chemically mutagenized topiramate derivative for pharmaceutical sample analysis

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2022-12-19
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Ahmed Abdulhafez Hamad
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