Ramzy Sherif, Abdelazim Ahmed H, Hasan Mohamed A
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Al-Azhar University, 11751 Nasr City, Cairo, Egypt.
BMC Chem. 2022 Aug 19;16(1):62. doi: 10.1186/s13065-022-00855-5.
Fexofenadine hydrochloride and pseudoephedrine hydrochloride are prescribed in a combined dosage form for the treatment of allergic rhinitis. In the present work, a sensitive synchronous fluorescence spectroscopic method was applied in conjunction with first derivative for quantitative estimation of fexofenadine hydrochloride and pseudoephedrine hydrochloride in pure form, pharmaceutical tablets and spiked human plasma. Fexofenadine hydrochloride showed its conventional emission spectrum at 294 nm when excited at 267 nm. On the other hand, pseudoephedrine hydrochloride showed its conventional emission spectra at 286 nm when excited at 261 nm. The fluorescence intensities were greatly enhanced by the use of sodium dodecyl sulphate as a micellar surfactant. Application of the synchronous mode to measure the fluorescence spectra of the above drugs provided sharp narrowing bands, but the overlap was not completely resolved. Derivatization of the synchronous spectra to the first order completely resolved the overlap of the fluorescence spectra and allowed simultaneous quantitative determination of the drugs under study. Fexofenadine hydrochloride and pseudoephedrine hydrochloride could be determined from their first-order synchronous spectra at 286 and 294 nm, respectively, without interfering with each other. The method showed linearity with an excellent correlation coefficient in the concentration range of 100-1500 ng/mL for Fexofenadine hydrochloride and 50-1000 ng/mL for pseudoephedrine hydrochloride. The method was successfully applied for the simultaneous determination of the studied drugs in pharmaceutical formulation, with mean percent recoveries for Fexofenadine hydrochloride and pseudoephedrine hydrochloride of 99.49 ± 0.931 and 98.67 ± 0.634, respectively, and in spiked human plasma, with mean percent recoveries for Fexofenadine hydrochloride and pseudoephedrine hydrochloride of 95.21 ± 1.938 and 94.89 ± 1.763, respectively. Furthermore, the greenness of the described method was assessed using four different tools namely, the national environmental method index, the analytical eco-scale, the green analytical procedure index and the AGREE evaluation method. The proposed method seemed to be superior to the reported HPLC method with respect to the metrics of the greenness characters.
盐酸非索非那定和盐酸伪麻黄碱以复方剂型用于治疗过敏性鼻炎。在本研究中，一种灵敏的同步荧光光谱法结合一阶导数用于定量测定纯品、药片中的盐酸非索非那定和盐酸伪麻黄碱以及加样人血浆中的这两种药物。盐酸非索非那定在267nm激发时，在294nm处呈现其常规发射光谱。另一方面，盐酸伪麻黄碱在261nm激发时，在286nm处呈现其常规发射光谱。通过使用十二烷基硫酸钠作为胶束表面活性剂，荧光强度大大增强。采用同步模式测量上述药物的荧光光谱得到了尖锐变窄的谱带，但重叠部分未完全分辨。将同步光谱进行一阶导数处理完全解决了荧光光谱的重叠问题，并允许同时定量测定所研究的药物。盐酸非索非那定和盐酸伪麻黄碱可分别从其在286nm和294nm处的一阶同步光谱中测定，且互不干扰。该方法在盐酸非索非那定浓度范围为100 - 1500ng/mL、盐酸伪麻黄碱浓度范围为50 - 1000ng/mL时呈线性，相关系数优异。该方法成功应用于同时测定药物制剂中的所研究药物，盐酸非索非那定和盐酸伪麻黄碱的平均回收率分别为99.49±0.931和98.67±0.634；在加样人血浆中，盐酸非索非那定和盐酸伪麻黄碱的平均回收率分别为95.21±1.938和94.89±1.763。此外，使用四种不同工具即国家环境方法指数、分析生态规模、绿色分析程序指数和AGREE评估方法对所述方法的绿色度进行了评估。就绿色度指标而言，所提出的方法似乎优于已报道的高效液相色谱法。
