Development of a new HPLC method for the simultaneous determination of ticarcillin and clavulanic acid in pharmaceutical formulations

Tai Li Tsou, Chiu Wey Lee, Hsian-Jenn Wang, Ya Chung Cheng, Yu Tien Liu, Su Hwei Chen

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1 Citation (Scopus)

Abstract

A new HPLC method has been developed and validated for the simultaneous determination of ticarcillin (TIC) and clavulanic acid (CA) in pharmaceutical formulations. The HPLC separation was achieved on a β-cyclodextrin column (Cyclobond I, 250 × 4.6 mm, 5 μm) with methanol-16 mM pH 6.0 ammonium acetate buffer (50 + 50, v/v) mobile phase at a flow rate of 0.8 mL/min. Detection was at 220 nm. Validation of the method was performed by evaluating specificity, robustness, accuracy, and precision. The calibration curves were linear in the range of 1-100 μg/mL for CA and 2-200 μg/mL for TIC. The LOQs based on the standard regression lines were 0.42 and 1.42 μg/mL for CA and TIC, respectively, and the LOD were 0.14 and 0.47 μg/mL, respectively. Total recoveries of synthetic mixtures (CA:TIC = 1:10, 1:15, and 1:30) were 99.25-100.99% for CA and 99.54-100.82% for TIC. Compared with the U.S. Pharmacopeia method, the proposed method has the advantage of a relatively low flow rate and short analysis time. The proposed method was successfully applied for the simultaneous determination of these two drugs in sterilized H 2O and 5% dextrose injection solutions.

Original languageEnglish
Pages (from-to)1089-1094
Number of pages6
JournalJournal of AOAC International
Volume92
Issue number4
Publication statusPublished - Jul 1 2009

ASJC Scopus subject areas

  • Analytical Chemistry
  • Food Science
  • Environmental Chemistry
  • Agronomy and Crop Science
  • Pharmacology

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