Spectrofluorometric determination of alogliptin an antidiabetic drug in pure and tablet form using fluorescamine, a fluorogenic agent: application to content uniformity test

Abstract

Alogliptin is an antidiabetic drug that belongs to a group called dipeptidyl peptidase-4 enzyme inhibitors. As the drug contains a primary amino group in its structure, it readily reacts with fluorescamine in slightly alkaline medium (borate buffer, pH 8.8) to form a highly fluorescent product. Emission of this product was measured at 477 nm (λ ex = 387 nm). The linear range between the fluorescence intensity and the drug concentration was 0.1-0.5 μg ml −1 with a good correlation coefficient (0.9986). Limits of detection and quantitation were 22 and 72 ng ml −1 , respectively. Guidelines of the International Conference for Harmonisation were followed to validate the developed method with acceptable results. Alogliptin content was determined successfully in its commercial dosage form using the fluorescamine method with good recovery (98.60-101.26%). The method has excellent levels of accuracy and precision compared with the reported method as assessed using Student's t-test and Fisher's exact test. The method was applied successfully for the content uniformity test with high recovery and low relative standard deviation.

Hantzsch condensation reaction as a spectrofluorometric method for determination of alogliptin, an antidiabetic drug, in pure form, tablet form, and human and rat plasma

“…T A B L E 7 Proposed spectrofluorimetric method application to determine ALO in spiked human plasma UV/Vis spectrophotometry 1-25 [25] UV/Vis spectrophotometry 5-30 [34] HPLC 0.05-1 [30] Spectrofluorometry 0.1-0.5 [38] UV-vis spectrophotometry and (RP-HPLC) 5-35 and 20-100 [7]…”

“…[ 1–3 ] ALO’s scientific name is 2‐[[6‐[(3R)‐3‐aminopiperidin‐1‐yl]‐3‐methyl‐2,4‐dioxopyrimidin‐1‐yl][2]methyl]benzonitrile (Figure 1) with empirical formula C 18 H 21 N 5 O 2. [ 4 ] Some attempts have been made to estimate ALO either alone or in conjunction with other medications, including using capillary electrophoresis, [ 5 ] conductometry, [ 6 ] high performance liquid chromatography (HPLC), [ 7–30 ] spectrophotometry, [ 7,17,31–36 ] spectrofluorometry, [ 37,38 ] and thin‐layer chromatography [ 27,39–41 ] methods. The use of costly reagents (e.g.…”

“…to estimate ALO either alone or in conjunction with other medications, including using capillary electrophoresis, [5] conductometry, [6] high performance liquid chromatography (HPLC), spectrophotometry, [7,17,[31][32][33][34][35][36] spectrofluorometry, [37,38] and thin-layer chromatography [27,[39][40][41] methods. The use of costly reagents (e.g.…”

“…fluorescamine, dansyl chloride), hazardous organic solvents used in extraction (e.g., chloroform and dichloromethane), or an absence of adequate sensitivity for biological fluids analysis are some of the major drawbacks of previously described methods. [38][39][40][41] Because of its excellent sensitivity and low cost, the Hantzsch condensation reaction is used to detect amino groups in some pharmaceutically important substances. [42,43] It aims to develop a spectrofluorimetric method for determining alogliptin in pharmaceutical preparations, human plasma samples, and real rat plasma samples that is selective, precise, accurate, and less time consuming.…”

Construction and application of highly sensitive spinel nanocrystalline zinc chromite decorated multiwalled carbon nanotube modified carbon paste electrode (ZnCr2O4@MWCNTs/CPE) for electrochemical determination of alogliptin benzoate in bulk and its dosage form: green chemistry assessment

“…ALG has been determined spectrophotometric, 9–11 spectrofluorometric, 12,13 chromatographic, 14–20 and HPTLC. 21 While the literature review revealed no electrochemical method.…”