PMID- 20352926
OWN - NLM
STAT- MEDLINE
DCOM- 20131212
LR  - 20161018
IS  - 1000-8713 (Print)
IS  - 1000-8713 (Linking)
VI  - 27
IP  - 6
DP  - 2009 Nov
TI  - [Analysis of solvent residues in raw material drug of glimepiride by head-space 
      sampling-capillary gas chromatography].
PG  - 755-9
AB  - An analytical method for the solvent residues in the raw material drug of 
      glimepiride has been established by head-space sampling capillary gas 
      chromatography. General evaluation was made for the distribution of organic 
      residual solvents in glimepiride samples from 8 different domestic manufacturers. 
      Based on the evaluation-test results and the information provided by 
      manufacturers, 14 target solvents were ascertained including acetone, ethyl 
      acetate, methanol, isopropanol, ethanol, chloroform, toluene, 1,4-dioxane, 
      pyridine, chlorobenzene, ether, dichloromethane, n-hexane and benzene. The target 
      solvents were divided into two groups for baseline separation according to their 
      column-retention specificity. Acetone, ethyl acetate, methanol, isopropanol, 
      ethanol, chloroform, toluene, 1,4-dioxane, pyridine and chlorobenzene were 
      separated on a Supelco-Wax capillary column with acetonitrile as internal 
      standard, while ether, dichloromethane, n-hexane and benzene were determined on a 
      Supelco OVI-G43 capillary column with butanone as internal standard. Linear 
      responses were obtained for the 14 residual solvents in their respective 
      concentration ranges (r = 0.99167-0.99997, n = 8), and the limits of detection 
      were 0.2-13.5 microg/g. The inter-day reproducibilities, measured as relative 
      standard deviations (RSDs), were 0.6%-9.2% (n = 3). The average recoveries of 
      three concentration levels were 86.3%-104.1% with the RSD of 0.2%-5.3% (n = 16). 
      The developed method is simple, sensitive, and accurate for the residual solvent 
      analysis in glimepiride samples.
FAU - Zhu, Bo
AU  - Zhu B
AD  - Qingdao Institute for Drug Control, Qingdao 266071, China. zhu_bo@163.com
FAU - Zhao, Luqing
AU  - Zhao L
FAU - Chen, Anzhen
AU  - Chen A
FAU - Hua, Yuqin
AU  - Hua Y
FAU - Luan, Chengzhang
AU  - Luan C
LA  - chi
PT  - English Abstract
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - China
TA  - Se Pu
JT  - Se pu = Chinese journal of chromatography
JID - 9424804
RN  - 0 (Solvents)
RN  - 0 (Sulfonylurea Compounds)
RN  - 6KY687524K (glimepiride)
SB  - IM
MH  - Chromatography, Gas/*methods
MH  - Drug Contamination
MH  - Solvents/*analysis
MH  - Sulfonylurea Compounds/*analysis
EDAT- 2010/04/01 06:00
MHDA- 2013/12/18 06:00
CRDT- 2010/04/01 06:00
PHST- 2010/04/01 06:00 [entrez]
PHST- 2010/04/01 06:00 [pubmed]
PHST- 2013/12/18 06:00 [medline]
PST - ppublish
SO  - Se Pu. 2009 Nov;27(6):755-9.