Chiral Resolution and Content Determination of Ketorolac Tromethamine Using High-performance Liquid Chromatography

(E-pub Ahead of Print)

Author(s): Lei Zheng*, Jing Yang, Yu-yao Guan, Lei Zhang, Chao Song, Xiao-li Zhang

Journal Name: Current Pharmaceutical Analysis

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Background: Establishing R, S-enantiomer (S-KT and R-KT) chiral resolution and determination methods for KT are of great significance.

Objective: This study aimed to establish a high-performance liquid chromatography (HPLC) method for the resolution and determination of ketorolac tromethamine (KT) enantiomers.

Methods: A CHIRALPAK AGP column (0.4  10 cm, 5 μm) was used with 10 mmol/L ammonium acetate (pH 5.5) and isopropanol (97:3) as the mobile phase. The detection wavelength was 324 nm, the flow rate was 1.0 mL/min, the column temperature was 25°C, and the injection volume was 5 μL.

Results: The resolution between S-KT and R-KT was 2.8. S-KT and R-KT demonstrated a good linear relationship in the range of 3-60 μg/mL (r > 0.999). The average recoveries of S-KT and R-KT were 99.2% and 99.8%, with relative standard deviations of 2.0% and 2.4%, respectively.

Conclusion: The established method can be used for the resolution and determination of S-KT and R-KT.

Keywords: Ketorolac tromethamine; enantiomers; HPLC; chiral resolution; determination

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(E-pub Ahead of Print)
DOI: 10.2174/1573412917999201110203024

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