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<p>A novel green spectrofluorometric method was developed for the quantification of diltiazem hydrochloride (DLZ), a benzothiazepine-class calcium channel blocker with vasodilatory properties. The assay exploits the rapid fluorescence quenching of Acid Red 87—a fluorone-based dye—upon complexation with DLZ in acidic medium (pH 3.8). This “on-off” mechanism enables selective DLZ detection by measuring the decrease in Acid Red 87 native fluorescence intensity (λ<sub>ex</sub>/λ<sub>em</sub> = 302.5/545.8&#xa0;nm). Key parameters (pH, dye concentration, buffer volume) were systematically optimized, yielding a linear response over 50–1100 ng/mL (r² = 0.9991) with a detection limit of 15.5 ng/mL. The method was rigorously validated per ICH Q2(R1) guidelines, confirming precision (RSD &lt; 2%), accuracy (99.76% % recovery), and robustness. It was successfully applied to analyze DLZ in pharmaceutical formulations (tablets/capsules) with no matrix interference, and the statistical comparison (t- and F-tests) showed no significant difference from the reference method. Critically, the procedure uses distilled water as the sole solvent, aligning with green chemistry principles while offering simplicity, cost-efficiency, and high-throughput potential.</p>

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Employing intrinsic fluorone-dye fluorescence in a quenching-based (“on-off”) strategy for diltiazem determination in tablets and capsules

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  • 发表日期：

    2025年12月1日

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  • Ahmed A. Abu-hassan

摘要

A novel green spectrofluorometric method was developed for the quantification of diltiazem hydrochloride (DLZ), a benzothiazepine-class calcium channel blocker with vasodilatory properties. The assay exploits the rapid fluorescence quenching of Acid Red 87—a fluorone-based dye—upon complexation with DLZ in acidic medium (pH 3.8). This “on-off” mechanism enables selective DLZ detection by measuring the decrease in Acid Red 87 native fluorescence intensity (λex/λem = 302.5/545.8 nm). Key parameters (pH, dye concentration, buffer volume) were systematically optimized, yielding a linear response over 50–1100 ng/mL (r² = 0.9991) with a detection limit of 15.5 ng/mL. The method was rigorously validated per ICH Q2(R1) guidelines, confirming precision (RSD < 2%), accuracy (99.76% % recovery), and robustness. It was successfully applied to analyze DLZ in pharmaceutical formulations (tablets/capsules) with no matrix interference, and the statistical comparison (t- and F-tests) showed no significant difference from the reference method. Critically, the procedure uses distilled water as the sole solvent, aligning with green chemistry principles while offering simplicity, cost-efficiency, and high-throughput potential.