Fast chiral chromatographic method development and validation for the quantitation of eszopiclone in human plasma using LC/MS/MS.
J Pharm Biomed Anal
; 53(4): 973-82, 2010 Dec 01.
Article
in En
| MEDLINE
| ID: mdl-20650591
ABSTRACT
Traditional chiral chromatographic separation method development is time consuming even for an experienced chromatographer. This paper describes the application of computer software ACD Lab to facilitate the development of chiral separation for the quantitation of eszopiclone using LC-MS/MS technology. Assisted by ACD/Chrom Manager and LC Simulator software, the optimal chiral chromatographic development was completed within hours. The baseline chiral separation was achieved with a total cycle time of 3 min. For sample extraction method development, a Waters Oasis Sorbent Selection Plate containing four different sorbents was utilized. Optimal conditions were determined using a single plate under various load, wash and elution conditions. This was followed by a GLP validation which demonstrated excellent intra- and inter-day accuracy and precision for the quantitation of eszopiclone in human plasma at 1.00-100 ng/mL range using LC/MS/MS technology. This method was utilized to support multiple clinic bioequivalence studies.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Piperazines
/
Chromatography, Liquid
/
Tandem Mass Spectrometry
/
Azabicyclo Compounds
/
Hypnotics and Sedatives
Limits:
Humans
Language:
En
Journal:
J Pharm Biomed Anal
Year:
2010
Type:
Article
Affiliation country:
United States