Journal of Bioequivalence & Bioavailability

A rapid HPLC method for ranitidine quantification: Application for in situ intestinal perfusion studies

6^th World Congress on Bioavailability & Bioequivalence: BA/BE Studies Summit

August 17-19, 2015 Chicago, USA

Thaisa M Dezani, Andre B Dezani, Monica M C Silva and Cristina H R Serra

Posters-Accepted Abstracts: J Bioequiv Availab

Abstract:

Absorption prediction of drugs has been grown in recent years and studies involving in vivo, ex vivo and in situ methods are applied
for permeability assessment of substances. Single-Pass Intestinal Perfusion (SPIP) is a technique employed for absorption studies
prediction using an intestinal segment. This work aims to show a chromatographic method developed and validated for ranitidine
(RNT) quantification from perfusate samples. A simple, precise, specific and accurate RP-HPLC (reversed-phase high performance
liquid chromatography) method was developed and validated for RNT using ICH guideline considering parameters as selectivity/
specificity, linearity, precision, accuracy, limit of detection and limit of quantification. The chromatographic conditions were achieved
with: Gemini C18 column (150 mm x 4.6 mm x 5 μm), ultraviolet detection at 315nm (RNT) and 270 nm (zidovudine as internal
standard), oven set at 30°C. The mobile phase consisted of phosphate buffer 10 mM, methanol and acetonitrile (65:30:5) pH 7.2, flow
of 1 mL/min and injection volume of 75 μL. The assessed parameters were in accordance with the recommendations. The method
presented linearity in a range of 5-150 μg/mL (r²=0.9999). Precision and accuracy are also adequate with intraday and interday
variation below 5%. No interferences were noticed in chromatograms, reflecting the selectivity and specificity of the method. The
chromatographic method was developed and validated for RNT quantification in perfusate samples and its applicability in daily lab
routine is possible. Also, this method can be useful for development of other chromatographic methods in SPIP studies, especially in
co-perfusion situation. This study had financial support by FAPESP, CAPES and CNPq (Brazil).

Biography :

Thaisa M Dezani has completed her Master’s degree in 2012 and since then, she is developing her PhD thesis related to permeability studies using different methods as in
situ, ex vivo and in vitro models. Her research field also includes solubility, biopharmaceutical classification systems, dissolution studies and ADME prediction. The studies
are conducted in Faculty of Pharmaceutical Sciences of University of Sao Paulo, Brazil.