Determination of the enantiomeric impurity in S-(-)pantoprazole using high performance liquid chromatography with sulfobutylether-beta-cyclodextrin as chiral additive

Journal of Separation Science
Jin GuanFamei Li

Abstract

A new and accurate HPLC method using sulfobutylether-beta-cyclodextrin (SBE-beta-CD) as chiral mobile phase additive (CMPA) was developed and validated for the determination of R-(+)pantoprazole in S-(-)pantoprazole. The influences of type and concentration of CD, ACN content and buffer pH of mobile phase on the resolution and retention of enantiomers were investigated. A baseline resolution of pantoprazole enantiomers was achieved on a Spherigel C18 column (150 mm x 4.6 mm, 5 microm) using ACN and 10 mM phosphate buffer (pH 2.5) containing 10 mM SBE-beta-CD (15:85 v/v) as mobile phase with a flow rate of 0.9 mL/min at 20 degrees C. The detection wavelength was set at 290 nm. The method was extensively validated in terms of accuracy, precision and linearity according to the International Conference on Harmonisation (ICH) guidelines and proved to be robust. The LOD and LOQ for R-(+)pantoprazole were 0.2 and 0.5 microg/mL, respectively, with 5 microL injection volume. A good linear relationship was obtained in the concentration range of 0.5-6.0 microg/mL with r(2) >0.999 for R-(+)pantoprazole. The percentage recovery of the R-(+)pantoprazole ranged from 92.1 to 101.2 in bulk drug of S-(-)pantoprazole. The method is capable of det...Continue Reading

References

Feb 5, 2002·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Q B CassJ Pedrazolli
Sep 9, 2004·Journal of Separation Science·M Jesús del NozalJuan J Jiménez
Aug 4, 2005·Journal of Pharmaceutical and Biomedical Analysis·Sarah K Branch
Sep 24, 2005·Pharmaceutical Research·Zhiyong XieDafang Zhong
May 5, 2006·Journal of Pharmaceutical and Biomedical Analysis·Muzaffar KhanG Sreenivas Reddy

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Citations

Jul 20, 2010·Annual Review of Analytical Chemistry·A M Stalcup
Feb 18, 2016·International Journal of Analytical Chemistry·Yangfeng PengJiang Cai
Jan 8, 2013·Journal of Separation Science·Anna RoccoSalvatore Fanali
May 26, 2010·Analytical Chemistry·Timothy J Ward, Karen D Ward

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