Reversed-phase liquid chromatographic separation of complex samples by optimizing temperature and gradient time

“…Even when chromatographers are careful to keep buffer strengths constant during modification of organic solvent strengths, effective analyte pK a changes and mobile-phase pH changes as a result of solvent strength, which can cause changes in ionization state of compounds, changes in the resultant mobilephase pH, and/or changes in the behavior of chromatographic columns [25]. Departures from linearity can be particularly striking in acetonitrile as opposed to methanol.…”

Section: Off-line Optimizationmentioning

confidence: 99%

Computer‐Assisted HPLC and Knowledge Management

Kazakevich

McBrien²,

LoBrutto

2006

HPLC for Pharmaceutical Scientists

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“…A number of reviews and applications of the computer simulation software have been reported in the literature [10][11][12]. In an effort to improve the efficiency of method development, computer simulation software was used for the separation of the isomers of Palonosetron hydrochloride.…”

Section: Introductionmentioning

confidence: 99%

Enantioseparation of Palonosetron Hydrochloride and Its Related Enantiomeric Impurities by Computer Simulation and Validation

Murthy¹,

Krishnaiah²,

Jyothirmayi³

et al. 2011

AJAC

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A rapid, simple and single stereo selective high-performance liquid chromatographic (HPLC) method was developed and validated for enantiomers of palonosetron hydrochloride (PALO) and its process related chiral impurities. A computer simulating software was used for the development of chiral method. The developed method was able to separate not only the enantiomers of palonosetron hydrochloride but also its process related chiral impurities within 12 min. The chromatographic separation was carried out by normal phase chromatography using a 3 µm column of cellulose based chiral stationary phase (Chiralcel-OD 250mm × 4.6mm) with a mobile phase comprised of n-hexane: ethanol: methanol: heptafluoro butyric acid: diethyl amine (70:15:15:0.05:0.1, v/v) at a flow rate of 1.0 mL/min. The effects of additive concentration as well as nature of polar organic modifier, flow rate, and temperature on enantioselectivity were investigated. The limit of detection (LOD) and limit of quantification (LOQ) of the palonosetron isomers and its related chiral impurities were found to be in the range 0.06-0.10 µg/mL and 0.14 -0.24 µg/mL respectively. The method showed excellent linearity (R 2 > 0.998) over a range of 0.14 to 1.125 µg/mL. The percentage recovery of the isomers in bulk drug samples ranged from 87.0 to 116.0.

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Reversed-phase liquid chromatographic separation of complex samples by optimizing temperature and gradient time

Cited by 160 publications

References 19 publications

A novel stop-flow two-dimensional liquid chromatography–mass spectrometry method for lipid analysis

A novel stop-flow two-dimensional liquid chromatography–mass spectrometry method for lipid analysis

Computer‐Assisted HPLC and Knowledge Management

Enantioseparation of Palonosetron Hydrochloride and Its Related Enantiomeric Impurities by Computer Simulation and Validation

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