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利用超高效液相色谱法的分离能力同时测定福尔可定、愈创木酚以及三种特定愈创木酚杂质。

Exploiting the power of UPLC in separation and simultaneous determination of pholcodine, guaiacol along with three specified guaiacol impurities.

作者信息

Mohamed Hager M, Zaazaa Hala E, Abdelkawy M, Tantawy Mahmoud A

机构信息

Pharmaceutical Chemistry Department, Faculty of Pharmacy, Future University in Egypt, Cairo, Egypt.

Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr el Aini Street, Cairo, 11562, Egypt.

出版信息

BMC Chem. 2023 Apr 13;17(1):35. doi: 10.1186/s13065-023-00949-8.

Abstract

Pholcodine and guaiacol are widely used together in pharmaceutical syrups for cough treatment. On the other hand, the Ultra Performance Liquid Chromatographic technique is characterized by having the power of increasing chromatographic efficiency and decreasing run time compared to the traditional High Performance Liquid Chromatographic one. In this work, this power was exploited for the simultaneous determination of pholcodine, guaiacol along with three guaiacol impurities, namely; guaiacol impurity A, guaiacol impurity B, and guaiacol impurity E. Good separation was achieved by employing Agilent Zorbax C8 column (50 × 2.1 mm) as the stationary phase, and acetonitrile: phosphate buffer pH 3.5 (40: 60, by volume) as a mobile phase. The proposed method was validated as per International Council for Harmonisation guidelines. Linear relationships, at ranges of 50-1000 µg mL for pholcodine and 5-100 µg mL for guaiacol and the three related impurities, were established. Finally, the proposed method was applied for pholcodine and guaiacol determination in Coughpent® syrup and compared favorably to the reported one.

摘要

福尔可定和愈创甘油醚在止咳糖浆中广泛联用。另一方面,超高效液相色谱技术的特点是与传统高效液相色谱技术相比,具有提高色谱效率和缩短运行时间的能力。在本研究中,利用这种能力同时测定福尔可定、愈创甘油醚以及三种愈创甘油醚杂质,即愈创甘油醚杂质A、愈创甘油醚杂质B和愈创甘油醚杂质E。采用安捷伦Zorbax C8柱(50×2.1 mm)作为固定相,乙腈:pH 3.5的磷酸盐缓冲液(体积比40:60)作为流动相,实现了良好的分离效果。所提出的方法按照国际协调理事会的指导原则进行了验证。建立了福尔可定在50 - 1000 μg/mL范围内、愈创甘油醚及三种相关杂质在5 - 100 μg/mL范围内的线性关系。最后,将所提出的方法应用于测定Coughpent®糖浆中的福尔可定和愈创甘油醚,并与已报道的方法进行了比较,结果良好。

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