Ibrahim F A, Fathy M E, Elmansi H M
Faculty of Pharmacy, Pharmaceutical Analytical Chemistry Department, Mansoura University, Mansoura, Egypt.
Luminescence. 2019 Feb;34(1):77-83. doi: 10.1002/bio.3579. Epub 2018 Dec 11.
Orciprenaline sulphate (ORP) is a direct-acting sympathomimetic with mainly beta-adrenoceptor stimulant activity. It is used as a bronchodilator in the management of reversible airway obstruction. For the first time, a rapid highly sensitive spectrofluorimetric method is described that is relied on measuring the fluorescence spectra of ORP at acidic pH and without addition of any chemical reagents. The relative fluorescence intensity was measured at 310 nm and after excitation at 224 nm. ORP native fluorescence was calibrated in both water and acetonitrile as diluting solvents. The method was designed to estimate the drug in miscellaneous matrices with high accuracy and precision. Linear ranges of calibration curves were 30.0-400.0 ng/ml and 10.0-240.0 ng/ml in water and acetonitrile, respectively. The detection limits were calculated and reached as low as 3.3 and 3.1 ng/ml, respectively, representing the ultra-sensitivity of the proposed method. This result permitted application of this method for spiked human plasma and urine and was used as a preliminary investigation with good percentage recovery (89.4-106.8%). The application was further extended to analyse ORP in its pharmaceutical formulations. The method was validated in compliance with International Council of Harmonization (ICH) Guidelines.
硫酸奥西那林（ORP）是一种直接作用的拟交感神经药，主要具有β-肾上腺素能受体刺激活性。它在可逆性气道阻塞的治疗中用作支气管扩张剂。首次描述了一种快速、高灵敏度的荧光分光光度法，该方法依赖于在酸性pH条件下测量ORP的荧光光谱，且无需添加任何化学试剂。在224nm激发后，于310nm处测量相对荧光强度。以水和乙腈作为稀释溶剂对ORP的天然荧光进行了校准。该方法旨在高精度、高准确度地测定多种基质中的药物。水和乙腈中校准曲线的线性范围分别为30.0 - 400.0 ng/ml和10.0 - 240.0 ng/ml。计算得出的检测限分别低至3.3和3.1 ng/ml，表明该方法具有超灵敏度。这一结果使得该方法可应用于加标的人血浆和尿液，并作为初步研究，回收率良好（89.4 - 106.8%）。该应用进一步扩展至分析其药物制剂中的ORP。该方法按照国际协调理事会（ICH）指南进行了验证。
