Evaluation of liquid chromatography methods for the separation of ampicillin and its related substances

Zhang, Yongxin; Roets, Eugène; Ni, Zhigang; Moreno, M. L.; Porqueras, E.; Hoogmartens, Jos

doi:10.1016/0731-7085(95)01661-9

Cited by 9 publications

(13 citation statements)

References 20 publications

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“…Therefore, we could conclude that Peak 3 was an isomer of Peak 5. Considering that Peak 3 had a much shorter retention time than Peak 5, and with the comparison of related substances reported in the literature [ 1 ], Peak 3 was tentatively identified as L-ampicillin. Figure 5 showed the proposed MS fragmentation pathway for the fragmentation ions of L-ampicillin.…”

Section: Resultsmentioning

confidence: 98%

“…Based on diagnostic ions ( m / z 324.1, 307.1, and 175.1) and comparison with the published literature of known related substances of ampicillin [ 10 ], Peak 1 and Peak 2 were identified as isomers of ampicilloic acid. (5S, 6R) or (5R, 6R) ampicilloic acids were the two groups of ampicilloic acid isomers which were reported to be the metabolites and degradation products of ampicillin [ 1 ]. According to the retention behavior in reversed-phase chromatography of Peak 1 and Peak 2 and the related literature [ 1 ], Peak 1 and Peak 2 were tentatively identified as (5S, 6R) ampicilloic acid and (5R, 6R) ampicilloic acid, respectively.…”

Section: Resultsmentioning

confidence: 99%

“…(5S, 6R) or (5R, 6R) ampicilloic acids were the two groups of ampicilloic acid isomers which were reported to be the metabolites and degradation products of ampicillin [ 1 ]. According to the retention behavior in reversed-phase chromatography of Peak 1 and Peak 2 and the related literature [ 1 ], Peak 1 and Peak 2 were tentatively identified as (5S, 6R) ampicilloic acid and (5R, 6R) ampicilloic acid, respectively. Figure 4 showed the proposed MS fragmentation pathway for the fragmentation ions of ampicilloic acid.…”

Section: Resultsmentioning

confidence: 99%

“…In recent years, the requirement of quality control for related substances in chemicals became stricter no matter in structure confirmation or content limitation. Ampicillin was especially degradable in presence of aqueous solution or humid storage environment, which would lead to the formation of a variety of degradation products [ 1 ]. These related substances (the related substances previously reported were shown in Table 1 ) would have a great influence on the quality of the products and clinical medication safety.…”

Section: Introductionmentioning

confidence: 99%

“…Many analytical methods including high-performance liquid chromatography (HPLC) [ 1 , 5 ], high-performance capillary electrophoresis (HPCE) [ 6 ], high-performance liquid chromatography-atmospheric pressure chemical ionization mass (HPLC-APCI-MS) [ 7 ], and high-performance liquid chromatography-electrospray mass spectrometry (HPLC-ESI-MS) [ 8 , 9 ] had been utilized for the analysis of ampicillin. Among these methods, LC-ESI-MS had been shown to be a powerful technique for the analysis of ampicillin and its related substances due to its excellent ability in separation and identification.…”

Section: Introductionmentioning

confidence: 99%

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Identification of the Related Substances in Ampicillin Capsule by Rapid Resolution Liquid Chromatography Coupled with Electrospray Ionization Tandem Mass Spectrometry

Zhang

Cheng

Liu

et al. 2014

Journal of Analytical Methods in Chemistry

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Rapid Resolution Liquid Chromatography coupled with Electrospray Ionization Tandem Mass Spectrometry (RRLC-ESI-MSn) was used to separate and identify related substances in ampicillin capsule. The fragmentation behaviors of related substances were used to identify their chemical structures. Finally, a total of 13 related substances in ampicillin capsule were identified, including four identified components for the first time and three groups of isomers on the basis of the exact mass, fragmentation behaviors, retention time, and chemical structures in the literature. This study avoided time-consuming and complex chemosynthesis of related substances of ampicillin and the results could be useful for the quality control of ampicillin capsule to guarantee its safety in clinic. In the meantime, it provided a good example for the rapid identification of chemical structures of related substances of drugs.

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Section: Resultsmentioning

confidence: 98%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Identification of the Related Substances in Ampicillin Capsule by Rapid Resolution Liquid Chromatography Coupled with Electrospray Ionization Tandem Mass Spectrometry

Zhang

Cheng

Liu

et al. 2014

Journal of Analytical Methods in Chemistry

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Antibiotics, Pharmaceutical Analysis of

Gilpin

Pachla³

2000

Encyclopedia of Analytical Chemistry

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An antibiotic is a chemical substance, produced by microorganisms (or recently, synthetic routes) which has the capacity to inhibit the growth of other microorganisms/bacterial agents. The terminology for antibiotics stems from the Latin term of antibiosis and the noun antibiotic was coined by Professor Waksman in 1942. Considered as a single therapeutic class, antibiotics are one of the most diverse groups of medicinal agents. They can be grouped into several subclasses depending on their source, structure and activity. These are the cephalosporins, penicillins, quinolones, streptomyces and tetracycline. In addition to these agents, the sulfonamides and other miscellaneous compounds are also included owing to their antibacterial activity.

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Determination of the purity of ampicillin by micellar electrokinetic chromatography and reversed phase liquid chromatography on a monolithic silica column

Kunteová

Jobánek

2004

J of Separation Science

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A micellar electrokinetic chromatographic (MEKC) method and a fast reversed-phase liquid chromatographic one have been developed for determining the purity of ampicillin. MEKC separation of ampicillin and its related substances was performed with the use of an untreated fused-silica capillary and 40 mM phosphate-borate buffer, pH 7.5 containing 75 mM SDS. The HPLC method employed a monolithic silica C18 column and a mobile phase composed of phosphate buffer, pH 5.2 and ACN, the flow rate being 4.0 mL/min. Both methods were successfully validated. Linearity, relative response factors, limits of quantitation, intermediate precision, and accuracy were evaluated. The methods proved to be fast, reliable, and sufficiently sensitive and, accordingly, well-suited for control of purity of ampicillin substance, injections, and capsules. A combination of both methods can be very useful in the confirmation of impurity profiles.

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Evaluation of liquid chromatography methods for the separation of ampicillin and its related substances

Cited by 9 publications

References 20 publications

Identification of the Related Substances in Ampicillin Capsule by Rapid Resolution Liquid Chromatography Coupled with Electrospray Ionization Tandem Mass Spectrometry

Identification of the Related Substances in Ampicillin Capsule by Rapid Resolution Liquid Chromatography Coupled with Electrospray Ionization Tandem Mass Spectrometry

Antibiotics, Pharmaceutical Analysis of

Determination of the purity of ampicillin by micellar electrokinetic chromatography and reversed phase liquid chromatography on a monolithic silica column

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