ACADEMIA ROMÂNĂ Revue Roumaine de Chimie http://web.icf.ro/rrch/ Rev. Roum. Chim., 2019, 64(10), 859-866 DOI: 10.33224/rrch.2019.64.10.04 DEVELOPMENT OF REVERSE PHASE LIQUID CHROMATOGRAPHIC METHOD BY USING CORE SHELL PARTICLES COLUMN FOR DETERMINATION OF MONTELUKAST AND LEVOCETIRIZINE FROM PHARMACEUTICAL CAPSULE DOSAGE FORMS Cem ERKMEN, Selda ZENGİN KURNALI and Bengi USLU * Ankara University, Faculty of Pharmacy, Department of Analytical Chemistry, 06560, Ankara, Turkey Received November 20, 2018 The aim of this paper is to develop a reverse phase high performance liquid chromatographic method with UV detection using the new generation core-shell columns to analyze montelukast and levocetirizine. For this aim, the mobile phase compositions, buffer solutions at different concentrations, pH, flow rate and temperature effects are optimized for the separation of drug compounds. The chromatographic separation was achieved on Kinetex ® C 18 (150 mm x 4.6 mm, 5μm) as stationary phase. Mobile phase consist of methanol:10 mM ammonium acetate buffer (85:15, v/v) pH 4.0 at a flow rate of 1.5 mL min -1 , column temperature of 40 º C and UV detection at 240 nm. The proposed this method was used successfully for simultaneous determination of montelukast and levocetirizine in capsule dosage forms. INTRODUCTION * Rhinitis is an inflammation of the nose’s mucous lining. Some symptoms such as sneezing, rhinorrhea, itching, nasal obstruction and post nasal drip are seen in Rhinitis. While asthma has been known as symptoms of lower respiratory tract diseases, allergic rhinitis has been known as symptoms of upper respiratory tract diseases. Airway hypersensitivity, early phase allergic reactions and late phase allergic reactions, can be seen in both the lungs and nose simultaneously. 1 Montelukast sodium (MON) is a potent active and specific leukotriene receptor antagonist. Also, it was approved for the treatment of seasonal allergic rhinitis and asthma’s symptoms by the US Food and Drug Administration (FDA). 2–4 It’s chemical * Corresponding author: buslu@pharmacy.ankara.edu.tr name is 2-[1-[1(R)-[3-[2(E)-(7-chloroquinolin-2- yl)vinyl] phenyl]- 3[2-(1-hydroxy-1-me- thylethyl)phenyl]propylsulfanylmethyl] cyclopro- pyl] acetic acid sodium salt (Fig. 1). 5 Levocetiriz- ine (LEV) is a second generation antihistamine. It was approved by the FDA for the treatment of perennial allergic rhinitis and seasonal allergic rhinitis’ symptoms. 6 It’s chemical name is (I), 2-[2-[4-[(R)-(4-chlorophenyl)-phenyl-methyl] piperazinyl-1-yl]ethoxy] acetic acid and it is the R-enantiomer of racemic cetirizine. 7 Theoretically, combination of LEV and MON may enhance treating nasal symptoms’ therapeutic effectiveness. There are different pharmaceutical dosage forms combination of LEV and MON that effect inhibition of both early phase and late phase reactions in allergic rhinitis. 1