A rapid extraction method was developed and validated for esomeprazole determination in rabbit plasma by liquid chromatography tandem mass spectrometry (LC–MS/MS). Esomeprazole in rabbit plasma was extracted and then cleaned up using QuEChERS technique. The analyte was separated using C18 column and quantified by MS/MS detector. Pantoprazole was used as the internal standard. The positive ESI source was used in this study together with the multi-reactive ion monitoring mode. The validity of the method has been confirmed in accordance with ICH Harmonized guidelines on bioanalytical method validation. The method showed good specificity, good stability, with the linearity varying from 0.1 ng/mL to 20 ng/mL, the lower limit of quantification was 0.1 ng/mL, the accuracy and precision were within 85% and 115% which achieved the ICH Harmonized guideline requirements, FDA guideline and AOAC International requirements. The method has been applied to quantify the concentration of esomeprazole in rabbit plasma, and then to compare the bioavailability of two preparations containing esomeprazole.
Esomeprazole, Pantoprazole, LC-MS/MS, rabbit plasma, QuEChERS
[1]. Astrazeneca, "Nexium ® (esomeprazole magnesium) delayed - release capsules", 2006.
[2]. Medication guide nexium, 2018.
[3]. S. Missaghi, C. Young, K. Fegely, and A. R. Rajabi-Siahboomi, "Delayed release film coating applications on oral solid dosage forms of proton pump inhibitors: case studies," Drug development and industrial pharmacy, vol. 36, no. 2, pp. 180-189, 2010.
[4]. W. Talaat, "Bioanalytical method for the estimation of co-administered esomeprazole, leflunomide and ibuprofen in human plasma and in pharmaceutical dosage forms using micellar liquid chromatography", Biomedical Chromatography, vol. 31, no. 5, 2017.
[5]. R. H. B. Chunduri and G. S. Dannana, "Development and validation of a high throughput UPLC-MS/MS method for simultaneous quantification of esomeprazole, rabeprazole and levosulpiride in human plasma", Journal of Pharmaceutical Analysis, vol. 6, no. 3, pp. 190-198, 2016.
[6]. E. F. Elkady, M. A. Fouad, and B. M. Jaadan, "LC-MS/MS bioassay of four proton pump inhibitors", Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, vol. 1076, pp. 61-69, 2018.
[7]. M. Anastassiades, S. J. Lehotay, D. Stajnbaher, and F. J. Schenck, "Fast and easy multiresidue method employing acetonitrile extraction/partitioning and "dispersive solid-phase extraction" for the determination of pesticide residues in produce", Journal of AOAC International, vol. 86, no. 2, pp. 412-31, 2003.
[8]. United States Food and Drug Administration, Bioanalytical Method Validation Guidance for Industry, 2018.
[9]. ICH, ICH guideline M10 on bioanalytical method validation, 2019.
[10]. AOAC International, “Appendix F: Guidelines for Standard Method Performance”, AOAC official methods of analysis, 2016.
[11]. B. Y. tế, Dược điển Việt Nam V, Phụ lục 14 Hướng dẫn đánh giá sinh khả dụng và tương đương sinh học in vivo thuốc generic, Nhà xuất bản Y học, 2017.
[12]. United States Food and Drug Administration, Guidance for industry: estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers, 2015.