Development of a Novel HPLC Method for the Analysis of Impurities in Meropenem and Identification of Unknown Impurities by 2D LC-IT-TOF MS

Ren, Xiaojuan; Ye, Jingjing; Chen, Xianming; Wang, Fan; Liu, Guijun; Wang, Jian

doi:10.1007/s10337-021-04081-4

Cited by 7 publications

(3 citation statements)

References 13 publications

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“…Using 2D-LC, scientists tried to study the active ingredient of meropenem and quantify the ring-opened meropenem and meropenem dimer, known as A and B, with LODs of 0.07 μg·mL −1 and 0.22 μg·mL −1 , respectively, and LOQs of 0.25 μg·mL −1 and 0.74 μg·mL −1 , respectively. 2D-LC was also used to identify three new degradation impurities, and the results were evaluated using ESI-MS/MS data [ 43 ]. Another paper described the quantification of amoxicillin, benzylpenicillin, benzylpenicillin, flucloxacillin, and piperacillin, as well as the beta-lactamase inhibitors clavulanic acid and clindamycin, macrolide antibiotics, and tazobactam clindamycin [ 44 ].…”

Section: The Application Of 2d-lc In Antibiotics Analysismentioning

confidence: 99%

Two-Dimensional High-Performance Liquid Chromatography as a Powerful Tool for Bioanalysis: The Paradigm of Antibiotics

Papatheocharidou,

Samanidou

2023

Molecules

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The technique of two-dimensional high-performance liquid chromatography has managed to gain the recognition it deserves thanks to the advantages of satisfactory separations it can offer compared to simple one-dimensional. This review presents in detail key features of the technique, modes of operation, and concepts that ensure its optimal application and consequently the best possible separation of even the most complex samples. Publications focusing on the separation of antibiotics and their respective impurities are also presented, providing information concerning the analytical characteristics of the technique related to the arrangement of the instrument and the chromatographic conditions.

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Section: The Application Of 2d-lc In Antibiotics Analysismentioning

confidence: 99%

Two-Dimensional High-Performance Liquid Chromatography as a Powerful Tool for Bioanalysis: The Paradigm of Antibiotics

Papatheocharidou,

Samanidou

2023

Molecules

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“…The identification and analysis of impurities in drug products are important due to their potential gene toxicity . Nonvolatile salts in the mobile phase can provide a stable pH environment that helps stabilize the structure of drug and impurities so that a better liquid chromatography (LC) separation can be achieved . Most of the LC methods in pharmacopeias use nonvolatile salts and buffers as a mobile phase to analyze crude drugs, and the establishment of LC methods without nonvolatile salts is often difficult/laborious.…”

mentioning

confidence: 99%

“…4 Nonvolatile salts in the mobile phase can provide a stable pH environment that helps stabilize the structure of drug and impurities so that a better liquid chromatography (LC) separation can be achieved. 5 Most of the LC methods in pharmacopeias use nonvolatile salts and buffers as a mobile phase to analyze crude drugs, 6 and the establishment of LC methods without nonvolatile salts is often difficult/laborious. For example, dipotassium phosphate is used as a mobile phase to analyze erythromycin, and nonvolatile salt buffers also serve the separation of omeprazole as a mobile phase in LC.…”

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confidence: 99%

Heat-Assisted Dual Neutral Spray Ionization for High-Performance Online Desalting in Mass Spectrometric Analysis

et al. 2022

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In mass spectrometry (MS), nonvolatile salts contaminate the transmission system and cause ion suppression, hampering MS analysis. When MS is combined with liquid chromatography (LC) that uses a salty mobile phase, the problems become more intractable due to long analysis time. Here, a novel heat-assisted dual neutral spray ionization (HADSI) method was developed, which projected sample solution spray and solvent spray onto a heated plate to achieve online desalting and high ionization. The experimental parameters of HADSI were optimized, which indicated that the plate temperature was crucial for ionization and desalination. Eight drug compounds dissolved in various commonly used buffers were directly analyzed using HADSI-MS, even though the concentration of PBS buffer reached 500 mmol/L. The established method showed considerable sensitivity in the positive ion mode with the limits of detection at the level of nmol/L, and good linearity (R 2 > 0.99) was achieved for all the analyzed compounds. The repeatability and intra-and interday precisions of the method were evaluated, demonstrating the feasibility and reliability of the analysis of salty samples by HADSI-MS. Further, the method was demonstrated to tolerate the long-time analysis of high-salt LC eluates and the device was easy to maintain. Finally, a crude roxithromycin product was separated by LC and then analyzed by HADSI-MS, and seven unknown impurities and nine known impurities were successfully detected. Our results indicated that HADSI-MS may have potential applications in academic and industrial fields.

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Trapping mode two-dimensional liquid chromatography for quantitative low-level impurity enrichment in pharmaceutical development

Lin

Wang

Zhou

et al. 2023

Journal of Chromatography A

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Development of a Novel HPLC Method for the Analysis of Impurities in Meropenem and Identification of Unknown Impurities by 2D LC-IT-TOF MS

Cited by 7 publications

References 13 publications

Two-Dimensional High-Performance Liquid Chromatography as a Powerful Tool for Bioanalysis: The Paradigm of Antibiotics

Two-Dimensional High-Performance Liquid Chromatography as a Powerful Tool for Bioanalysis: The Paradigm of Antibiotics

Heat-Assisted Dual Neutral Spray Ionization for High-Performance Online Desalting in Mass Spectrometric Analysis

Trapping mode two-dimensional liquid chromatography for quantitative low-level impurity enrichment in pharmaceutical development

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