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