Download PDF
Arzneimittelforschung 2010; 60(5): 262-266
DOI: 10.1055/s-0031-1296283
Antiemetics · Gastrointestinal Drugs · Urologic Drugs
Editio Cantor Verlag Aulendorf (Germany)

Liquid chromatography–tandem mass/mass spectrometry method for the quantification of rabeprazole in human plasma and application to a pharmacokinetic study

Liyan Yu
1   Center for Instrumental Analysis, China Pharmaceutical University, Key Laboratory of Drug Quality Control and Pharmacovigilance under the Ministry of Education, Nanjing, Jiangsu Province, People's Republic of China
,
Haishan Deng
2   College of Pharmacy, Nanjing University of Chinese Medicine, Nanjing, Jiangsu Province, People's Republic of China
,
Bingren Xiang
1   Center for Instrumental Analysis, China Pharmaceutical University, Key Laboratory of Drug Quality Control and Pharmacovigilance under the Ministry of Education, Nanjing, Jiangsu Province, People's Republic of China
› Author Affiliations
Further Information

Publication History

Publication Date:
02 December 2011 (online)

    Permissions and Reprints

Abstract

A rapid, simple and sensitive reversedphase high-performance liquid chromatographic-tandem mass/mass spectrometry (HPLC/MS/MS) method has been developed for the measurement of rabeprazole (CAS 117976-89-3) concentrations in human plasma and its use in bioavailability studies has been evaluated. The method was linear in the concentration range of 0.05 −2.5 μg/ml. The lower limit of quantification (LLOQ) was 0.05 μg/ml in 1ml plasma sample. The intra- and inter-day relative standard deviation across three validation runs over the entire concentration range was less than 8.2% and 7.53%, respectively. This method was successfully applied for the evaluation of pharmacokinetic profiles of rabeprazole tablet in 18 healthy volunteers. The main pharmacokinetic parameters obtained were: AUC0–t 1415.88 ± 505.46 and 1457.44 ± 524.40 ng · h/ml, AUC0–∞ 1439.10 ± 507.47 and 1479.81 ± 527.83 ng h/ml, Cmax 678.24 ± 278.93 and 657.83 ± 250.86 ng/ml, t1/2 1.48 ± 0.19 and 1.38 ± 0.24 h, tmax 3.8 ± 0.8 and 3.7 ± 0.5 h for the test and reference formulations, respectively. No statistical differences were observed for Cmax and the area under the plasma concentration time curve for rabeprazole. 90% confidence limits calculated for Cmax and AUC from zero to infinity (AUC0–∞) of rabeprazole were included in the bioequivalence range (0.8–1.25 for AUC).

Key words

CAS 117976-89-3 - HPLC/MS/MS - Proton-pump inhibitors - Rabeprazole, biological availability, pharmacokinetics
 

  • References

  • 1 Prakash A, Faulds D. Rabeprazole: new drug profile. Drugs. 1998; 55: 261-7
    CrossrefPubMedGoogle Scholar
  • 2 Rabinson M, Horn J. Clinical pharmacology of proton pump inhibitors: what the practising physician needs to know. Drugs. 2003; 63: 2739-54
    CrossrefPubMedGoogle Scholar
  • 3 Langtry HD, Markham A. Rabeprazole: a review of its use in acidrelated gastrointestinal disorders. Drugs. 1999; 58: 725-42
    CrossrefPubMedGoogle Scholar
  • 4 Chan LW, Chan WY, Heng PW. An improved method for the measurement of colour uniformity in pellet coating. Int J Pharm. 2001; 213: 63-74
    CrossrefPubMedGoogle Scholar
  • 5 Takakuwa S, Chiku S, Nakata H, Yuzuriha T, Mano N, Asa-kawa N. Enantioselective high-performance liquid chromatographic assay for determination of the enantiomers of a new antiulcer agent, E3810, in Beagle dog plasma and rat plasma. J Chromatogr B. 1995; 673: 113-22
    PubMedGoogle Scholar
  • 6 Mano N, Oda Y, Takakuwa S, Chiku S, Nakata H, Asakawa N. Plasma direct injection high-performance liquid chromatographic method for simultaneously determining E3810 enantiomers and their metabolites by using flavoprotein-conjugated column. J Pharm Sci. 1996; 85: 903-7
    CrossrefPubMedGoogle Scholar
  • 7 Huang J, Xu Y, Gao S, Rui L, Guo Q. Development of a liquid chromatography/tandem mass spectrometry assay for the quantification of rabeprazole in human plasma. Rapid Commun. Mass Spectrom. 2005; 19: 2321-4
    CrossrefPubMedGoogle Scholar
  • 8 Feng S, Guangji W, Jianguo S, Haitang X, Hao L, Tian L et al. Liquid chromatographic/mass spectrometric assay of rabprazole in dog plasma for a pharmacokinetic study. Biomed Chromatogr. 2006; 20: 1136-41
    CrossrefPubMedGoogle Scholar
  • 9 Nakai H, Shimamura Y, Kanazawa T, Yasuda S, Kayano M. Determination of a new H+-K+ ATPase inhibitor (E3810) and its four metabolites in human plasma by high-performance liquid chromatography. J Chromatogr B. 1994; 660: 211-20
    PubMedGoogle Scholar
  • 10 Masatomo Miura, Hitoshi Tada, Shigeru Satoh, Tomonori Habuchi, Toshio Suzuki. Determination of rabeprazole enantiomers and their metabolites by high-performance liquid chromatography with solid-phase extraction,. J Pharmaceut Biomed. 2006; 41: 565-570
    CrossrefPubMedGoogle Scholar
  • 11 Zhang Y, Chen XY, Gu Q, Zhong DF. Quantification of rabeprazole in human plasma by liquid chromatography–tandem mass spectrometry. Anal Chim Acta. 2004; 523: 171-5
    CrossrefPubMedGoogle Scholar
  • 12 El-Gindy A, El-Yazby F, Maher MM. Spectrophotometric and chromatographic determination of rabeprazole in presence of its degradation products. J Pharm Biomed Anal. 2003; 31: 229-42
    CrossrefPubMedGoogle Scholar
  • 13 McLoughlin DA, Olah TV, Ellis JD, Gilbert JD, Halpin RA. Simultaneous determination of unlabeled and deuterium-labeled indinavir in human plasma by high-performance liquid chromatography with tandem mass spectrometric detection. J Chromatogr A. 1996; 726: 115-224
    CrossrefPubMedGoogle Scholar