Development and Validation of an HPLC Method for the Determination of the macrolide antibiotic Clarithromycin using Evaporative Light Scattering Detector in raw materials and Pharmaceutical Formulations

Authors

  • Zampia Tzouganaki Benaki Phytopathological Institute ,Department of Pesticides Control and Phytopharmacy Laboratory of Pesticides Toxicology Kifissia, Athens
  • Michael Koupparis Benaki Phytopathological Institute, Department of Pesticides Control and Phytopharmacy, Laboratory of Pesticides Toxicology, Kifissia, Athens

DOI:

https://doi.org/10.13171/mjc64/01706211420-tzouganaki

Abstract

In this work, ELS-Detector has been used for the development of an HPLC method for the determination of clarithromycin in pharmaceutical formulations (tablets and pediatric suspension). Isocratic reversed phase HPLC approach has been developed using a C-18 column (Waters Spherisorb 5 μm ODS2, 4.6x250 mm) and a mobile phase consisting of acetonitrile / aqueous trifluoroacetic acid as pairing reagent. Experimental parameters (temperature of heated drift tube, flow rate of mobile phase, gas flow rate, mobile phase composition) were optimized. Clarithromycin’ s stability was thoroughly examined in different solvent systems. Using the optimized conditions the working range was 5-100 μg/mL (upper limit can be increased considerably), with a detection limit of 4.5 μg/mL (6x10-6 M). The method was validated as per ICH guidelines. The retention time was 4.7 min. The method was successfully applied for the content assay of clarithromycin formulations.

Author Biography

Zampia Tzouganaki, Benaki Phytopathological Institute ,Department of Pesticides Control and Phytopharmacy Laboratory of Pesticides Toxicology Kifissia, Athens

Benaki Phytopathological Institute, Department of Pesticides Control and Phytopharmacy, Laboratory of Pesticides Toxicology, Kifissia, Athens

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Published

2017-06-21

Issue

Vol. 6 No. 4 (2017)

Section

Analytical Chemistry

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