Design and strategy for spectrofluorimetric determination of tranexamic acid in its authentic form and pharmaceutical preparations: application to spiked human plasma

Abstract

A creative, very sensitive and noncomplicated spectrofluorimetric technique was established and further validated to determine tranexamic acid in both its authentic form and its pharmaceutical preparation dosage forms. In the introduced technique, a reaction was found between the aliphatic primary amino group of tranexamic acid and ninhydrin/phenylacetaldehyde reagents in the presence of Torell and Steinhagen buffer pH 7.0, which led to the production of a highly fluorescent product; fluorescence intensity was measured at 475 nm after excitation at 391 nm. A calibration curve was drawn with a linear range of 0.3–2 μg/ml. Limit of detection and limit of quantification values were 0.051 and 0.155 μg/ml respectively. The introduced technique was validated based on the International Council for Harmonisation guidelines and agreed for determination of tranexamic acid in its pharmaceutical formulation. Finally, this simple method was also applied for determination of tranexamic acid in spiked human plasma.

An integrative analytical approach designed for feasible tranexamic acid assay using o‐phthalaldehyde as a fluorogenic probe: applications to tablets, ampoules, and urine

“…The TRX formulations are available as tablets (Kapron 500 mg) or ampoules (Bledex 500 mg/5 ml) in the Egyptian pharmacy. Both were examined using both the novel method and the previously published technique [21]. The findings of the formulation percentage recovery test were good and closely matched the label's value.…”

“…The findings of the formulation percentage recovery test were good and closely matched the label's value. Utilizing precision in the mean of the F ‐test and accuracy in the mean of the t ‐test in comparison to the reported [21] method, the relevance of the method was assessed. The tabulated values in Table 6 were higher than the estimated values, and a 95% confidence level indicated that there was no disagreement with the approach that had been presented.…”

“…The tabulated values in Table 6 were higher than the T A B L E 5 Selectivity assessment of the proposed method. T A B L E 6 Application of the current and reported methods [21] for TRX assay in dosage forms. estimated values, and a 95% confidence level indicated that there was no disagreement with the approach that had been presented.…”

“…A review of the published literature found several methods for assessing TRX‐recommended formulations or TRX‐containing biofluids. The reported methods include high‐performance liquid chromatography (HPLC) assay in tablets, urine, plasma, and ampoules [3–7]; electrochemical detection [8, 9]; capillary electrophresis [10, 11]; spectrophotometry [12–16]; and spectrofluorimetry using fluorogenic probes such as acetyl acetone [17], naphthalene‐2,3‐dicarboxaldehyde [18], fluorescamine [19], 4‐chloro‐7‐nitrobenzofurazan (NBD‐Cl) [20], and ninhydrin [21].…”

New validated spectrofluorimetric protocol for colistin assay through condensation with 2,2-dihydroxyindan-1,3-dione: application to content uniformity testing

“…Generally to assay drugs that have primary amine groups, 2,2-dihydroxyindan-1,3-dione is employed as a derivatizing agent in presence of phenylacetaldehyde. [23][24][25][26] The reagent reacts with the main amino moiety in the structure resulting in a highly yellow uorescent derivative. Precision, repeatability, and lower analytical cost are the main key benets that distinguish this condensation reaction.…”