Statistical Design Approach for Optimizing the Spectrofluorimetric Method for Quantifying Trazodone Hydrochloride

IF 1 4区 化学 Q4 CHEMISTRY, ANALYTICAL Journal of Analytical Chemistry Pub Date : 2024-06-21 DOI:10.1134/s1061934824700175
Nafisur Rahman, Shahroora Sameen, Mohammad Kashif, Mohd Nasir
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Abstract

A sensitive spectrofluorimetric method was developed to determine trazodone hydrochloride in its formulation and urine sample. The principle of the developed method is based on the formation of an ion pair complex at a pH of 4.27 between the analyte drug and eosin Y, followed by its extraction into dichloromethane and subsequent fluorescence measurement. The fluorescence of the extracted trazodone-eosin Y complex was recorded at 450 nm with an excitation wavelength of 350 nm. Recording the fluorescence was utilized to construct the calibration plot, which was found to be linear in the range of 32.0–1.50 × 103 ng/mL of trazodone hydrochloride. The influences of experimental variables, namely pH, volumes of eosin Y (2.90 × 10–3 M), and buffer solution (pH 4.27), on the fluorescence intensity were examined and optimized by response surface methodology via Box−Behnken design. The limits of detection and the limit of quantitation of the reported method are 9.50 and 28.79 ng/mL, respectively. The accuracy of the proposed method was evaluated for intra-day and inter-day precision in the range of 0.46 to 0.77% RSD. The content of trazodone hydrochloride in its dosage forms was determined by the developed method using the standard addition technique, and the results showed good recovery between 96.50 and 99.25%, with a standard analytical error of 1.54 × 10–5 to 2.86 × 10–4. Interval hypothesis testing confirmed that it is lower than ±2%; hence, there was no bias between the developed and reference methods. No interference was observed from the common excipients present in tablet formulations. The developed method was also successfully applied for the determination of trazodone in urine samples, and recovery of the drug was observed in the range of 90–98%.

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优化盐酸曲唑酮定量的光谱荧光比色法的统计设计方法
摘要 建立了一种灵敏的光谱荧光测定法来测定制剂和尿样中的盐酸曲唑酮。该方法的原理是在 pH 值为 4.27 时,分析药物与曙红 Y 形成离子对复合物,然后将其萃取到二氯甲烷中,再进行荧光测定。提取的曲唑酮-曙红 Y 复合物的荧光在 450 纳米波长处记录,激发波长为 350 纳米波长。利用记录的荧光构建校准图,发现校准图在盐酸曲唑酮 32.0-1.50 × 103 ng/mL 的范围内呈线性关系。实验变量包括 pH 值、曙红 Y 体积(2.90 × 10-3 M)和缓冲溶液(pH 4.27)对荧光强度的影响。该方法的检出限和定量限分别为 9.50 和 28.79 ng/mL。该方法的日内精密度和日间精密度范围为 0.46% 至 0.77% RSD。采用标准添加技术,用所建立的方法测定了盐酸曲唑酮剂型中的含量,结果表明回收率在96.50%至99.25%之间,标准分析误差为1.54 × 10-5 至2.86 × 10-4。区间假设检验证实,其误差低于±2%;因此,所开发的方法与参考方法之间不存在偏差。没有观察到片剂中常见辅料的干扰。所开发的方法还成功地用于测定尿样中的曲唑酮,药物回收率在 90-98% 之间。
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来源期刊
Journal of Analytical Chemistry
Journal of Analytical Chemistry 化学-分析化学
CiteScore
2.10
自引率
9.10%
发文量
146
审稿时长
13 months
期刊介绍: The Journal of Analytical Chemistry is an international peer reviewed journal that covers theoretical and applied aspects of analytical chemistry; it informs the reader about new achievements in analytical methods, instruments and reagents. Ample space is devoted to problems arising in the analysis of vital media such as water and air. Consideration is given to the detection and determination of metal ions, anions, and various organic substances. The journal welcomes manuscripts from all countries in the English or Russian language.
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