A New Solid-Phase Extraction Method for Determination of Pantoprazole in Human Plasma Using High-Performance Liquid Chromatography
Keywords:Pantoprazole, Solid-phase extraction, High-performance liquid chromatography, Human plasma
BACKGROUND: A new simple, selective and accurate high-performance liquid chromatographic (HPLC) method utilising solid-phase extraction for the determination of pantoprazole in human plasma samples has been developed.
AIM: The purpose of this paper was developing a new HPLC method suitable for the determination of pantoprazole in plasma samples, which enables simple and rapid isolation and concentration of the analysed drug.
METHODS: The chromatographic separation was accomplished on a LiChroCart LiChrospher 60 RP select B column using a mobile phase composed of 0.2 % (V/V) water solution of triethylamine (pH 7) and acetonitrile (58:42, V/V) followed by UV detection was at 280 nm. The solid-phase extraction method using LiChrolut RP-18 (200 mg, 3 ml) was applied to the obtained good separation of investigated drug from endogenous plasma components. Best results were achieved when plasma samples were buffered with 0.1 mol/L KH2PO4 (pH 9) before extraction, eluted and reconstituted with acetonitrile and 0.001 mol/L NaOH after extraction, respectively.
RESULTS: The standard calibration curves showed good linearity within the range of 25.0-4000.0 ng/mL with a correlation coefficient greater than 0.996. Retention times of pantoprazole and internal standard, lansoprazole was 4.1 and 6.0 min respectively. The limit of quantification was 25.0 ng/mL. For intra- and inter-day precision relative standard deviations ranged from 4.2 to 9.3%. The relative errors for stability investigations were ranged from 0.12 to -10.5%.
CONCLUSION: This method has good precision and accuracy and was successfully applied to the pharmacokinetic and bioequivalence study of 40 mg pantoprazole in healthy volunteers.
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Bharathi DV, Hotha KK, Jagadeesh B, Chatki PK, Thriveni K, Mullangi R, Naidu A. Simultaneous estimation of four proton pump inhibitors--lansoprazole, omeprazole, pantoprazole and rabeprazole: development of a novel generic HPLC-UV method and its application to clinical pharmacokinetic study. Biomed Chromatogr. 2009; 23(7):732-9. https://doi.org/10.1002/bmc.1177 PMid:19360758
Noubarani M, Keyhanfar F, Motevalian M, Mahmoudian M. Improved HPLC method for determination of four PPIs, omeprazole, pantoprazole, lansoprazole and rabeprazole in human plasma. J Pharm Pharm Sci. 2010; 13(1):1-10. https://doi.org/10.18433/J3GP4Q PMid:20456825
Emami J, Rezazadeh M, Kalani M. Quantification of pantoprazole by high performance liquid chromatography (HPLC) method: In vitro and in vivo applications. Journal of Liquid Chromatography & Related Technologies. 2014; 37(5):681-95. https://doi.org/10.1080/10826076.2012.758137
Ramakrishna NV, Vishwottam KN, Wishu S, Koteshwara M. High-performance liquid chromatography method for the quantification of pantoprazole in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2005; 822(1-2):326-9. https://doi.org/10.1016/j.jchromb.2005.06.011 PMid:16005696
Battu PR, Reddy NK. Development and validation of RP-HPLC for the pantoprazole sodium sesquihydrate in pharmaceutical dosage forms and human plasma. International Journal of ChemTech Research. 2009; 1(2):195-8.
Li Y, Ding MJ, Ma J, Wang S, Wu XL, Xu HJ, Lu ZY, Zou JJ, Fan HW, Zhou XM. Quantification of pantoprazole in human plasma using LC-MS/MS for pharmacokinetics and bioequivalence study. Eur J Drug Metab Pharmacokinet. 2011; 35(3-4):147-55. https://doi.org/10.1007/s13318-010-0018-5 PMid:21302042
Zarghi A, Shafaati A, Foroutan SM, Movahed H, Khoddam A. A rapid high-performance liquid chromatographic method for the determination of pantoprazole in plasma using UV detection. Application in pharmacokinetic studies. Arzneimittelforschung. 2008; 58(9):441-4. https://doi.org/10.1055/s-0031-1296536 PMid:18972873
KoÃ§yiÄŸit-KaymakÃ§oÄŸlu B, Unsalan S, Rollas S. Determination and validation of ketoprofen, pantoprazole and valsartan together in human plasma by high performance liquid chromatography. Pharmazie. 2006; 61(7):586-9.
Storms ML, Stewart JT. Development of a reversed-phase liquid chromatographic method for the analysis of amoxicillin, metronidazole, and pantoprazole in human plasma using solid-phase extraction. Journal of liquid chromatography & related technologies. 2002; 25(16):2433-43. https://doi.org/10.1081/JLC-120014265
Tanaka M, Yamazaki H. Direct determination of pantoprazole enantiomers in human serum by reversed-phase high-performance liquid chromatography using a cellulose-based chiral stationary phase and column-switching system as a sample cleanup procedure. Anal Chem. 1996; 68(9):1513-6. https://doi.org/10.1021/ac951127n PMid:8815744
Srinandan V, Nagappan K, Patel S, Yamjala K, Byran G, Babu B. Simultaneous Quantification of Pantoprazole and Levosulpiride in Spiked Human Plasma Using High Performance Liquid Chromatography Tandem Mass Spectrometry. Current Pharmaceutical Analysis. 2019; 15(1):17-23. https://doi.org/10.2174/1573412914666180101142646
Dotsikas Y, Apostolou C, Soumelas S, Kolocouri F, Ziaka A, Kousoulos C, Loukas YL. Validation of a novel, fully automated high throughput high-performance liquid chromatographic/tandem mass Spectrometric method for quantification of pantoprazole in human plasma. J AOAC Int. 2010; 93(4):1129-36.
Cass QB, Degani AL, Cassiano NM, Pedrazolli J Jr. Enantiomeric determination of pantoprazole in human plasma by multidimensional high-performance liquid chromatography. J Chromatogr B Analyt Technol Biomed Life Sci. 2002; 766(1):153-60. https://doi.org/10.1016/S0378-4347(01)00472-8
EMEA/CHMP/EWP/192217/2009 Rev.1 Corr.2. Guideline on Bioanalytical Method Validation. London, July 2011.
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Copyright (c) 2019 Dragica Zendelovska, Emilija Atanasovska, Kalina Gjorgjievska, Kristina Pavlovska, Krume Jakjovski, Dimce Zafirov, Jasmina Trojacanec (Author)
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