Universal response method for accurate quantitative analysis of the impurities in quinolone antibiotics using liquid chromatography coupled with diode array detector and charged aerosol detector

Jiarui Gao; Fan Wang; Bingqi Zhu; Ping Li; Zhijian Wang; Jian Wang

doi:10.1016/j.chroma.2023.464412

Universal response method for accurate quantitative analysis of the impurities in quinolone antibiotics using liquid chromatography coupled with diode array detector and charged aerosol detector

J Chromatogr A. 2023 Nov 8:1710:464412. doi: 10.1016/j.chroma.2023.464412. Epub 2023 Sep 24.

Authors

Jiarui Gao¹, Fan Wang², Bingqi Zhu³, Ping Li¹, Zhijian Wang², Jian Wang⁴

Affiliations

¹ Zhejiang University of Technology, Hangzhou 310014, China.
² Zhejiang Institute for Food and Drug Control, Key Laboratory for Core Technology of Generic Drug Evaluation National Medical Product Administration & Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Province, Hangzhou 310052, China.
³ Zhejiang Chinese Medical University, Hangzhou 310053, China.
⁴ Zhejiang University of Technology, Hangzhou 310014, China; Zhejiang Institute for Food and Drug Control, Key Laboratory for Core Technology of Generic Drug Evaluation National Medical Product Administration & Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Province, Hangzhou 310052, China. Electronic address: wangjianhw2000@163.com.

PMID: 37757529
DOI: 10.1016/j.chroma.2023.464412

Abstract

HPLC method is the standard method for the separation and quantification of impurities from quinolone antibiotics. However, due to the large differences in the UV absorption of the impurities in quinolone antibiotics, quantitative analysis without the availability of corresponding reference substances currently poses a challenge. A sensitive and direct method using high performance liquid chromatography coupled with diode array detector and charged aerosol detector (HPLC-DAD-CAD) was developed for the analysis of impurities in quinolone antibiotics. The chromatographic conditions were optimized for good separation and output signal of CAD detector by response surface method (RSM). The systematic variation of CAD parameter settings, such as nebulization temperature, filter constant and power function value (PFV), were used to study the effect of on the detector response of signal-to-noise ratios (S/N) and linearity for ofloxacin, ciprofloxacin and their impurities. In the method validation, good linearity of each component was obtained with coefficient of determination (r) greater than 0.999 in the range of 0.5-300 μg mL^-1. The average recoveries of each component were 99.02-102.39 % by DAD, were 98.22-101.91 % by CAD, RSDs were less than 2.5 % for intra-day and inter-day precision by DAD-CAD, with good precision and accuracy. The correction factor experimental results showed that the developed method provided a uniform response to the impurities with differences chromophores and could unbiasedly and directly detect the impurities in quinolone antibiotics. The method is first reported application of HPLC-DAD-CAD method for the analysis of impurities in quinolone antibiotics and it can be used for quality control of quinolone antibiotics.

Keywords: HPLC-DAD-CAD; Impurity accurate quantification strategy; Quinolone antibiotics; Uniform response; Universal detector.