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Chiral Resolution and Content Determination of Ketorolac Tromethamine using High-performance Liquid Chromatography
Current Pharmaceutical Analysis ( IF 0.7 ) Pub Date : 2021-11-30 , DOI: 10.2174/1573412917999201110203024
Lei Zheng 1 , Jing Yang 2 , Yu-yao Guan 1 , Lei Zhang 3 , Chao Song 1 , Xiao-li Zhang 1
Affiliation  

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 RKT 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.



中文翻译:

使用高效液相色谱法测定酮咯酸氨基丁三醇的手性分离度和含量

背景:建立R、S-对映体(S-KT和R-KT)手性拆分和KT的测定方法具有重要意义。

目的:本研究旨在建立一种用于拆分和测定酮咯酸氨丁三醇(KT)对映体的高效液相色谱(HPLC)方法。

方法:CHIRALPAK AGP 色谱柱(0.4 × 10 cm,5 μm),流动相为 10 mmol/L 醋酸铵(pH 5.5)和异丙醇(97:3)。检测波长为324 nm,流速为1.0 mL/min,柱温为25°C,进样量为5 μL。

结果:S-KT和R-KT的分辨率为2.8。S-KT 和 R-KT 在 3-60 μg/mL 范围内表现出良好的线性关系 (r > 0.999)。S-KT 和 RKT 的平均回收率分别为 99.2% 和 99.8%,相对标准偏差分别为 2.0% 和 2.4%。

结论:所建立的方法可用于S-KT和R-KT的分离和测定。

更新日期:2021-09-16
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