Separation and characterization of clindamycin and related impurities in bulk drug by high-performance liquid chromatography-electrospray tandem mass spectrometry

Zhou, Hui; Zheng, Zhong; Wu, Shihua; Tai, Yuanpo; Cao, Xiaoji; Pan, Yuanjiang

doi:10.1016/j.jpba.2006.02.014

Cited by 17 publications

(4 citation statements)

References 23 publications

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“…. The structure is different from reported dehydroclindamycin , the double bond was in different position, between C‐3′ and C‐4′. Neither of the two impurities has been included in the EP nor reported in any literature.…”

Section: Resultsmentioning

confidence: 56%

Isolation and identification of two unknown impurities from the raw material of clindamycin hydrochloride

Sun

Qin³

2014

J. Sep. Science

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Clindamycin hydrochloride belongs to the antibiotic family of lincomycin. It has the same antibacterial spectrum as lincomycin, but the antibacterial activity is four to eight times stronger than that of lincomycin. There have been some adverse reactions in clinical use of clindamycin hydrochloride and its finished drug products. The impurities in drugs are directly related to their safety. In this study, two unknown impurities were isolated from the raw material of clindamycin hydrochloride through various chromatographic methods. Their structures were identified as clindamycin isomer (impurity 1) and dehydroclindamycin (impurity 2) by mass spectrometry and NMR spectroscopy. Both of them were found for the first time. The two impurities exhibit a similar but lower antibacterial activity compared with clindamycin hydrochloride.

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Section: Resultsmentioning

confidence: 56%

Isolation and identification of two unknown impurities from the raw material of clindamycin hydrochloride

Sun

Qin³

2014

J. Sep. Science

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“…The developing method ESI-MS could solve some barriers in the area of identification and quantitative analysis of lincosamides [7][8][9]. The optimal mass spectrometric conditions for detection of most analytes were obtained in the positive ion mode, in which not only molecular ion is saved but some characteristic ions appear.…”

Section: Experimental Details and Resultsmentioning

confidence: 99%

Identification and Fragmentation of Cefalosporins, Lincosamides, Levofloxacin, Doxycycline, Vancomycin by ESI-MS

et al. 2017

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The aim of the paper is the identification of the most frequently used antibiotics such as cefazolin, cefuroxime, cefotaxime, ceftriaxone, ceftazidime, lyncomycin, clindamycin, levofloxacin, doxycycline and vancomycin by electrospray ionization mass spectrometry interface in positive and negative modes. The fragmentation pathways of the group of antibiotics were colligated on the basis of the obtained ESI mass spectra. Generally, the positive ion spectra of antibiotics are higher in intensity including an [M+H] + ion and producing less fragmentation as well as more informative compared to the negative ion spectra. Only ESI of levofloxacin in positive and negative modes with the chosen tune parameters leads to degradation of molecular ion, so the parent ion does not appear in the mass spectra. The group of antibiotics (cephalosporins and lincosamides) shows the same characteristic fragmentation. These setup parameters were successfully applied for the routine determination of antibiotics in their pharmaceutical dosage forms and other objects. Data base was developed for identification of antibiotics by comparison of their molecular and fragment ions.

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“…Thus, due to the high sensitivity of this technique, it does not demand prior tedious chromatographic extraction of the compound on a preparative scale. The tandem mass spectrometry can provide the online spectra; therefore, minimize the time for extraction and also reduce the solvent interference in the mass spectrum [32,33] . An example of the enormous specificity and sensitivity attain by tandem mass analysis is the characterization of clindamycin in which six impurities were detected with the online mode of analysis [34] .…”

Section: Mass Spectrometry Without Chromatographic Separationmentioning

confidence: 99%

A Review: Recent Trends in Analytical Techniques for Characterization and Structure Elucidation of Impurities in the Drug Substances

Parmar¹,

Shaik²

2021

ijps

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Parmar et al.: Recent Analytical Techniques for Characterization of ImpuritiesImpurity is an unwanted substance present in the active pharmaceutical ingredients that form during the synthesis process of active pharmaceutical ingredients or any unwanted constituent that is produced besides the active ingredient during the formulation or the aging of active pharmaceutical ingredients. Even the insignificant quantity of impurity existing in the medicinal product may harm the patient life and compromises the purity and superiority of the medicinal product. According to International council for harmonisation guidelines, analytical monitoring of impurity is a prerequisite and mandatory requirement for approval of market authorization of the new drug substance. Any pharmaceutical product would be capable to serve their intended therapeutic activity when they are free from impurity. Thus, an impurity existing in an active pharmaceutical ingredient needs to be identified and quantify with the help of modern analytical approaches. This review explores the basic information concerning impurity profiling, highlights the advantages of an analytical technique and also focuses on the limitation of different analytical methods for impurity profiling with possible ways to overcome the limitation.

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Separation and characterization of clindamycin and related impurities in bulk drug by high-performance liquid chromatography-electrospray tandem mass spectrometry

Cited by 17 publications

References 23 publications

Isolation and identification of two unknown impurities from the raw material of clindamycin hydrochloride

Isolation and identification of two unknown impurities from the raw material of clindamycin hydrochloride

Identification and Fragmentation of Cefalosporins, Lincosamides, Levofloxacin, Doxycycline, Vancomycin by ESI-MS

A Review: Recent Trends in Analytical Techniques for Characterization and Structure Elucidation of Impurities in the Drug Substances

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