Login Register Cart 0
Generic placeholder image

Current Pharmaceutical Analysis

Editor-in-Chief

ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

Back
Journal Home About Journal Editorial Board Journal Insight Current Issue Volumes/Issues
Subscribe
Research Article

Separation and Characterization of the Components and Impurities in Policresulen Solution using LC-Q-TOF MS

Author(s): Yunfeng Shi*, Qi Yao, Liqin Lin*, Xiaojuan Ren, Jie Ai and Yue Chen

Volume 19, Issue 3, 2023

Published on: 23 January, 2023

Page: [246 - 257] Pages: 12

DOI: 10.2174/1573412919666221223150943

Price: $65

conference banner
Abstract

Background: As an external medicine, policresulen solution didn't get much attention throughout the world. From the paper which had been published yet, there has been no report concerning other unknown impurities in the policresulen solution. Four known components had been identified as well as quantified, however, as long as people’s concern for drug safety increased rapidly, there still remain impurities to be studied.

Objective: This paper focuses on the separation and characterization of the impurities in the policresulen solution, which is critical for controlling the production of this drug.

Methods: The components and impurities in the policresulen solution were separated and characterized using HPLC coupled with to Q-TOF mass spectrometry. An ACE EXCEL 5 C18-PFP column (4.6 mm×250 mm, 5 μm) was used, and the mobile phases were 0.01 M ammonium acetate solution and methanol.

Results: 21 previously unknown impurities were separated and characterized in a policresulen solution, and the structures were proposed based on the MS/MS fragmentation data.

Conclusion: Based on the characterization of impurities, this study showed that there remain lots of oligomers in the policresulen solution, apart from four known components. This study could be used for further analytical analysis of the policresulen solution, which could improve the quality control of the policresulen solution and other preparations recommended in pharmacopoeias.

« Previous Next »
Graphical Abstract

[1]
Byk, G. Diphenylmethane derivative, processes for its preparation and medicaments containing it. Switzerland (SW) 1986.
[2]
Sha, W. Clinical observation on the treatment of cervical erosion with policresulen solution combined with policresulen suppository. China Health Industry, 2012, 30, 72-72.
[3]
Li, B.; Chen, X.; Yang, J. Determination of four components in policresulen vaginal suppositories by HPLC. Guide China Med., 2013, 11(36), 375-377.
[4]
Yang, Y-G.; Sun, G-X.; He, J. Determination the contents of three components in policresulen solution using reversed-phase high performance liquid chromatography. Pharm J Chin PLA, 2003, 19(4), 277-279.
[5]
Chinese Pharmacopoeia Commission. Chinese National Drug Standards: Beijing, 2008, 75, 145-146.
[6]
An, M.; Chang, Z.; Gao, L. Determination of four related substances in policresulen solution by HPLC. Yaowu Fenxi Zazhi, 2004, 24(5), 535-537.
[7]
Xu, J.; Chu, L.; Lu, J. Determination of m-cresol-6-sulfonic acid ammonium dimmer in policresulen solution by HPLC. Chin. Hosp. Pharm. J., 2005, 25(5), 437-438.
[8]
Shi, N. Determination of policerseilen vaginal suppositories by HPLC. China Pharm., 2014, 17(2), 318-320.
[9]
Rahman, N.; Azmi, S.N.H.; Wu, H.F. The importance of impurity analysis in pharmaceutical products: an integrated approach. Accredit. Qual. Assur., 2006, 11(1-2), 69-74.
[http://dx.doi.org/10.1007/s00769-006-0095-y]
[10]
Siddiqui, M.R.; AlOthman, Z.A.; Rahman, N. Analytical techniques in pharmaceutical analysis: A review. Arab. J. Chem., 2017, 10, S1409-S1421.
[http://dx.doi.org/10.1016/j.arabjc.2013.04.016]
[11]
Alothman, Z.; Rahman, N.; Siddiqui, M.R. Review on pharmaceutical impurities, stability studies and degradation products: an analytical approach. Rev. Adv. Sci. Eng., 2013, 2(2), 155-166.
[http://dx.doi.org/10.1166/rase.2013.1039]
[12]
Liu, G.; Zhu, B.; Ren, X.; Wang, J. Characterization of 28 unknown impurities in 16-membered macrolides by liquid chromatography coupled with ion trap/time-of-flight mass spectrometry. J. Pharm. Biomed. Anal., 2020, 186, 113324.
[http://dx.doi.org/10.1016/j.jpba.2020.113324]
[13]
Wang, J.; Wang, D. Characterization of allergic polymerized impurities in cephalosporins by MALDI-TOF MS/MS spectrometry. Curr. Pharm. Anal., 2022, 18(7), 719-731.
[http://dx.doi.org/10.2174/1573412918666220330003952]
[14]
Niculau, E.S.; de Oliveira, D.A.B.; Carvalho, L.L.; Nogueira, K.L.; Oliveira, M.C.A. Volatile chemical profile of ethanol-based hand sanitizer marketed in Brazil by HS-SPME/GC-MS. Curr. Pharm. Anal., 2022, 18(7), 732-738.
[http://dx.doi.org/10.2174/1573412918666220117163508]
[15]
Ren, X.; Zhou, J.; Hu, F.; Wang, J. Study of the impurity profile and characteristic fragmentation of Δ 3 ‐isomers in cephapirin sodium using dual liquid chromatography coupled with ion trap/time‐of‐flight mass spectrometry. Rapid Commun. Mass Spectrom., 2020, 34(23), e8948.
[http://dx.doi.org/10.1002/rcm.8948] [PMID: 32957160]
[16]
Liu, G.; Zhu, B.; Wang, F.; Ren, X.; Li, Y.; Zhang, F.; Wang, J. Quantitative analysis of impurities in leucomycin bulk drugs and tablets: A high performance liquid chromatography-charged aerosol detection method and its conversion to ultraviolet detection method. J. Pharm. Biomed. Anal., 2021, 202, 114148.
[http://dx.doi.org/10.1016/j.jpba.2021.114148] [PMID: 34052548]
[17]
Wang, J.; Zhou, J.; Xu, Y.; Zhu, B.; Jin, Y. Characterization of two unknown impurities in roxithromycin by 2D LC–QTOF/MS/MS and NMR. J. Pharm. Biomed. Anal., 2020, 184, 113196.
[http://dx.doi.org/10.1016/j.jpba.2020.113196] [PMID: 32113121]
[18]
He, L.; Qian, J.; Zhu, P.; Yang, W.; She, Y. Separation and characterization of unknown impurities in latamoxef sodium by LC-Q-TOF MS and a summary of their positive-ion fragmentation regularities. J. Pharm. Biomed. Anal., 2019, 175, 112793.
[http://dx.doi.org/10.1016/j.jpba.2019.112793] [PMID: 31377652]
[19]
Xiaojuan, R.; Zhou, J.; Wang, J. Separation and characterization of impurities and isomers in cefpirome sulfate by liquid chromatography/tandem mass spectrometry and a summary of the fragmentation pathways of oxime-type cephalosporins. Rapid Commun. Mass Spectrom., 2020, 35(4), e9004.
[http://dx.doi.org/10.1002/rcm.9004]
[20]
Li, Y.; Kong, X.; Hong, L.; Yue, C.; Wang, X.; Zhu, P. Characterization of an unknown impurity in indobufen tablets by HPLC-Q-TOF MS and NMR. Curr. Pharm. Anal., 2021, 17(7), 885-891.
[http://dx.doi.org/10.2174/1573412916999200616124632]
[21]
Husain, A.; Iram, F.; Siddiqui, A.A. Identification of metabolic pathways involved in the biotransformation of eslicarbazepine acetate using UPLC-MS/MS, human microsomal enzymes and in silico studies. J. King Saud Univ. Sci., 2021, 33(2), 101281.
[http://dx.doi.org/10.1016/j.jksus.2020.101281]

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy