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Ion-pair high-performance liquid chromatographic assay method for the assessment of clarithromycin stability in aqueous solution and in gastric juice
Affiliation:1. Research Institute of Pharmaceutical Sciences, Kyungpook National University, Daegu, 41566, Republic of Korea;2. BK21 Plus KNU Multi-Omics Based Creative Drug Research Team, Kyungpook National University, Daegu, 41566, Republic of Korea;3. College of Pharmacy, Kyungpook National University, Daegu, 41566, Republic of Korea;4. College of Pharmacy, Dankook University, Cheon-an, 31116, Republic of Korea;1. IBA Laboratory, Lebanese Atomic Energy Commission-CNRS, P.O. Box: 11-8281, Beirut, Lebanon;2. Faculty of Sciences, Lebanese University, Beirut, Lebanon;3. Faculty of Pharmacy, Alexandria University, P.O. Box: 21521, Elmesalla, Alexandria, Egypt;1. DuPont Crop Protection, Stine-Haskell Research Center, Newark, DE 19714, USA;2. Bruker UK Limited, Banner Lane, Coventry CV4 9GH, UK;3. Bruker BioSpin, Silberstreifen, 76287 Rheinstetten, Germany;1. Escola Universitària Salesiana de Sarrià, Pg. Sant Joan Bosco 74, 08017, Barcelona, Spain;2. Biomaterials, Biomechanics and Tissue Engineering group, Technical University of Catalonia, Pav. E, Av. Diagonal 647, Barcelona, Spain;3. School of Dentistry, Universitat Internacional de Catalunya, C/ Inmaculada 22, Barcelona, Spain;4. MDRCBB-Minnesota Dental Research Center for Biomechanics and Biomaterials, Department of Restorative Sciences, University of Minnesota School of Dentistry, 16-250A Moos Tower, 515 Delaware St. SE, Minneapolis, MN, 55455, United States;1. Sumitomo Dainippon Pharma Co., Ltd., 3-45 Kurakakiuchi 1-chome, Ibaraki-shi, Osaka 567-0878, Japan;2. School of Pharmaceutical Sciences, University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan;1. School of Engineering and Technology, Central Michigan University, Mt. Pleasant, MI, USA;2. Science of Advanced Materials, Central Michigan University, Mt. Pleasant, MI, USA;3. Department of Materials Engineering, University of British Columbia, Vancouver, BC V6T 1Z4, Canada;4. Corrosion Control Research Cell, Department of Metallurgy and Materials Engineering, University of the Punjab, Lahore 54590, Pakistan
Abstract:A simple and selective ion-pair HPLC method has been developed for the analysis of clarithromycin in aqueous solutions and in gastric juice. A Hypersil ODS 5-μm (150 × 4.6 mm I.D.) column was used with a mobile phase consisting of acetonitrile-aqueous 0.05 M phosphate buffer (pH 4.6) containing 5 mM 1-octanesulphonic acid (50:50, v/v). The column temperature was 50°C and detection was by UV absorption (210 nm). The limits of detection of 50-μl samples were 0.4 μg/ml (aqueous) and 0.78 μg/ml (0.5 ml gastric juice) or better. The assay was linear in the range of 1.56 to 100 μg/ml with r2 values greater than 0.99. The recovery from the gastric juice samples was 98.5±2.9%. The method was applied successfully to determine the stability of clarithromycin in 0.01 M HCl and gastric juice.
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