2015
DOI: 10.1016/j.jpba.2015.03.028
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Development and validation of LC methods for the separation of misoprostol related substances and diastereoisomers

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Cited by 6 publications
(8 citation statements)
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“…reference standard (batch N°3.0) was obtained from EDQM (European Directorate for the Quality of Medicines) Strasbourg. If the chromatogram of the assay showed additional peaks, the sample was also tested for related substances according to Kahsay et al [28].…”
Section: Sample Analysismentioning
confidence: 99%
“…reference standard (batch N°3.0) was obtained from EDQM (European Directorate for the Quality of Medicines) Strasbourg. If the chromatogram of the assay showed additional peaks, the sample was also tested for related substances according to Kahsay et al [28].…”
Section: Sample Analysismentioning
confidence: 99%
“…Tablets of the same batch stored in intact blisters at 25 °C and 60% RH for six months are shown as comparison (blue line). HPLC analysis for related substances was carried out according to Kahsay et al [ 35 ].…”
Section: Resultsmentioning
confidence: 99%
“…As expected, damage to the primary packaging had a strong detrimental influence on stability (Fig 2a and S1 Table): already after two months at 40˚C and 75% RH, the misoprostol content was out of specifications, and after six months the remaining amount of misoprostol was as low as 48.2% of the declared content. HPLC analysis of this sample for related substances according to Kahsay et al [35] clearly showed the decrease of the misoprostol content and the concomitant increase of the typical degradation products of misoprostol, i.e. misoprostol A and, to a smaller extent, misoprostol B and 8-epi-misoprostol (Fig 3).…”
Section: Effect Of Damaged Blistersmentioning
confidence: 86%
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“…While the separation of enantiomers is usually achieved via the formation of a diastereomeric complex involving differential chiral interactions at the chiral stationary phase, diastereomers can mostly be separated using a chiral chromatography due to differences in physical and chemical properties [1,[3][4][5]. Enantiomers are usually separated by a chiral column in normal-phase liquid chromatography (NPLC) [6][7][8][9][10], reversed-phase liquid chromatography (RPLC) [11][12][13][14][15][16] or supercritical fluid chromatography (SFC) [17][18][19]. Another common approach for the separation of enantiomers by reversed-phase HPLC on achiral stationary phases (e.g., C8, C18) is to convert them into diastereomers by coupling with chiral derivatizing reagents (CDRs) [20].…”
Section: Introductionmentioning
confidence: 99%