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Quantitative Determination of Loratadine in Rat Plasma by LC–MS/MS Method and Its Application in a Bioavailability Study

  • Dandan Yang
  • Ruirui Li
  • Cai Jia
  • Fang Zhang
  • Shanshan Jiang
  • Peng Zhang
  • Guixia LingEmail author
Original
  • 17 Downloads

Abstract

A sensitive, simple and fast LC–MS/MS method was established and validated for the determination of loratadine in rat plasma. The preparation of plasma sample was completed through a one-step liquid–liquid extraction method. An UHPLC column Phenomenex Kinetex C18 (50 mm × 2.1 mm, 2.6 µm) was utilized to achieve the chromatography separation. Mobile phases A and B were acetonitrile and water with a ratio of 45:55 (v/v) under an isocratic gradient, both comprising 0.2% formic acid. Multiple reaction monitoring mode (MRM) was carried out on the triple quadrupole detection in position ionization mode with an electrospray ionization source, the transitions of m/z 383.1 → 337.2 and m/z 284.9 → 193.3 were used to determine loratadine and diazepam (internal standard), respectively. The total analysis run time was 3.5 min and the elution time of loratadine and diazepam occurred at 1.1 and 2.1 min, respectively. This method has the advantages of higher sensitivity (0.04 ng mL−1), wider linear range (0.04–400 ng mL−1, r2 > 0.995), shorter analysis time (3.5 min), needing only a smaller plasma volume (50 μL) and simple preparation process. The accuracy and precision of loratadine in all QC samples met the requirements. This novel method was successfully applied to a bioavailability research of loratadine nanosuspensions in rats.

Keywords

LC–MS/MS Loratadine Pharmacokinetics Bioavailability 

Notes

Acknowledgements

We would like to express our thanks to Feifei Peng, Li Qin and Huiyang He for their help in animal experiments.

Compliance with Ethical Standards

Conflict of Interest

The authors declare that they have no conflict of interest.

Research Involving Animal Studies

The animal studies were permitted by the Animal Ethics Committee of Shenyang Pharmaceutical University (Shenyang, China). Animal welfare and experimental procedures were carried out strictly in accordance with the guide for care and use of laboratory animals.

References

  1. 1.
    Patil P, Paradkar A (2006) Porous polystyrene beads as carriers for selfemulsifying system containing loratadine. AAPS Pharm Sci Tech 7:E199–E205CrossRefGoogle Scholar
  2. 2.
    Banerji A, Long AA, Camargo CA (2007) Diphenhydramine versus nonsedating antihistamines for acute allergic reactions: a literature review. Allergy Asthma Proc 28:418–426CrossRefGoogle Scholar
  3. 3.
    El-Hammadi M, Awad N (2012) Investigating the use of liquisolid compacts technique to minimize the influence of pH variations on loratadine release. AAPS Pharm Sci Tech 13:53–58CrossRefGoogle Scholar
  4. 4.
    Szabados-Nacsa A, Sipos P, Martinek T, Mándity I, Blazsó G, Balogh Á, Szabó-Révész P, Aigner Z (2011) Physico-chemical characterization and in vitro/in vivo evaluation of loratadine: dimethyl-b-cyclodextrin inclusion complexes. J Pharm Biomed Anal 55:294–300CrossRefGoogle Scholar
  5. 5.
    Hibert J, Radwanski E, Weglein R, Luc V, Perentesis G, Symchowicz S, Zampaglione N (1987) Pharmacokinetics and dose proportionality of loratadine. Clin Pharmacokinet 27:694–698CrossRefGoogle Scholar
  6. 6.
    Han X, Wang M, Ma Z, Xue P, Wang Y (2016) A new approach to produce drug suspension CO2-assisted effervescence to produce drug suspension. Colloids Surf B: Biointerfaces 143:107–110CrossRefGoogle Scholar
  7. 7.
    Wang Y, Han X, Wang J, Wang Y (2016) Preparation characterization and in vivo evaluation of amorphous tacrolimus suspension produced using CO2-assisted in situ nanoamorphization method. Int J Pharmaceutics 55:35–41CrossRefGoogle Scholar
  8. 8.
    Salem II, Idrees J, Al Tamimi JI (2004) Determination of loratadine in human plasma by liquid chromatography electrospray ionization ion-trap tandem mass spectrometry. J Pharm Biomed Anal 34:141–151CrossRefGoogle Scholar
  9. 9.
    Chen J, Zha Y, Gao K, Shi Z, Jiang X, Jiang W, Gao X (2004) A validated HPLC-ESI-MS method for the determination of loratadine in human plasma and its application to pharmacokinetic studies. Pharmazie 59:600–603PubMedGoogle Scholar
  10. 10.
    Elkomy MH, El Menshawe SF, Abou-Taleb HA, Elkarmalawy MH (2017) Loratadine bioavailability via buccal transferosomal gel: formulation, statistical optimization, in vitro/in vivo characterization, and pharmacokinetics in human volunteers. Drug Delivery 24:781–791CrossRefGoogle Scholar
  11. 11.
    Vlase L, Imre S, Muntean D, Leucuta SE (2007) Determination of loratadine and its active metabolite in human plasma by high-performance liquid chromatography with mass spectrometry detection. J Pharm Biomed Anal 44:652–657CrossRefGoogle Scholar
  12. 12.
    Verma S, Singh SK (2016) LC-ESI-MS/MS estimation of loratadine-loaded self-nanoemulsifying drug delivery systems in rat plasma: pharmacokinetic evaluation and computer simulations by GastroPlus ™. J Pharm Biomed Anal 24:10–21CrossRefGoogle Scholar
  13. 13.
    Patel BN, Sharma N, Sanyal M, Shrivastav PS (2010) LC-MS-ESI for the determination of loratadine and descarboethoxyloratadine in human plasma. J Chromatogr Sci 48:35–44CrossRefGoogle Scholar
  14. 14.
    Sora DI, Udrescu S, David V, Medvedovid A (2017) Validated ion pair liquid chromatography/fluorescence detection method for assessing the variability of the loratadine metabolism occurring in bioequivalence studies. Biomed Chromatogr 21:1023–1029CrossRefGoogle Scholar
  15. 15.
    Amini H, Ahmadiani A (2004) Rapid determination of loratadine in small volume plasma samples by high-performance liquid chromatography with fluorescence detection. J Chromatogr B 809:227–230CrossRefGoogle Scholar
  16. 16.
    Song S, Zhao D, Sun J, Miao Q, Liu X, Wang Y, Zhong L, Xu M, Zhang P (2016) Development of a UPLC–MS/MS method for the determination of lomefloxacin in rabbit aqueous humor and its application to a pharmacokinetic study. J Chromatogr B 1033:187–192CrossRefGoogle Scholar
  17. 17.
    European Medicines Agency (2011) Guidance on Bioanalytical Method Validation. http://www.ema.europa.eu/docs/en.GB/document.library/Scientific.guideline/2011/08/WC500109686. Accessed 10 May 2013

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  • Dandan Yang
    • 1
  • Ruirui Li
    • 1
  • Cai Jia
    • 1
  • Fang Zhang
    • 1
  • Shanshan Jiang
    • 1
  • Peng Zhang
    • 1
  • Guixia Ling
    • 1
    Email author
  1. 1.Shenyang Pharmaceutical UniversityShenyangChina

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