A rapid and sensitive microscale HPLC method for the determination of indomethacin in plasma of premature neonates with patent ductus arteriousus

M. A. Al Za'abi, G. H. Dehghanzadeh, R. L G Norris, B. G. Charles

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25 Citations (Scopus)

Abstract

Indomethacin (IND) is the drug of choice for the closure of a patent ductus arteriosus (PDA) in neonates. This paper describes a simple, sensitive, accurate and precise microscale HPLC method suitable for the analysis of IND in plasma of premature neonates. Samples were prepared by plasma protein precipitation with acetonitrile containing the methyl ester of IND as the internal standard (IS). Chromatography was performed on a Hypersil C 18 column. The mobile phase of methanol, water and orthophosphoric acid (70:29.5:0.5, v/v, respectively), was delivered at 1.5 mL/min and monitored at 270 nm. IND and the IS were eluted at 2.9 and 4.3 min, respectively. Calibrations were linear (r > 0.999) from 25 to 2500 μg/L. The inter- and intra-day assay imprecision was less than 4.3 % at 400-2000 μg/L, and less than 22.1% at 35 μg/L. Inaccuracy ranged from -6.0% to +1.0% from 35 to 2000 μg/L. The absolute recovery of IND over this range was 93.0-113.3%. The IS was stable for at least 36 h when added to plasma at ambient temperature. This method is suitable for pharmacokinetic studies of IND and has potential for monitoring therapy in infants with PDA when a target therapeutic range for IND has been validated.

Original languageEnglish
Pages (from-to)364-367
Number of pages4
JournalJournal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences
Volume830
Issue number2
DOIs
Publication statusPublished - Jan 18 2006

Fingerprint

Indomethacin
High Pressure Liquid Chromatography
Newborn Infant
Plasmas
Patent Ductus Arteriosus
Pharmacokinetics
Chromatography
Calibration
Methanol
Blood Proteins
Assays
Esters
Recovery
Temperature
Water
Monitoring
Therapeutics
Pharmaceutical Preparations

Keywords

  • HPLC
  • Indomethacin
  • Patent ductus arteriosus
  • Premature neonates

ASJC Scopus subject areas

  • Biochemistry

Cite this

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title = "A rapid and sensitive microscale HPLC method for the determination of indomethacin in plasma of premature neonates with patent ductus arteriousus",
abstract = "Indomethacin (IND) is the drug of choice for the closure of a patent ductus arteriosus (PDA) in neonates. This paper describes a simple, sensitive, accurate and precise microscale HPLC method suitable for the analysis of IND in plasma of premature neonates. Samples were prepared by plasma protein precipitation with acetonitrile containing the methyl ester of IND as the internal standard (IS). Chromatography was performed on a Hypersil C 18 column. The mobile phase of methanol, water and orthophosphoric acid (70:29.5:0.5, v/v, respectively), was delivered at 1.5 mL/min and monitored at 270 nm. IND and the IS were eluted at 2.9 and 4.3 min, respectively. Calibrations were linear (r > 0.999) from 25 to 2500 μg/L. The inter- and intra-day assay imprecision was less than 4.3 {\%} at 400-2000 μg/L, and less than 22.1{\%} at 35 μg/L. Inaccuracy ranged from -6.0{\%} to +1.0{\%} from 35 to 2000 μg/L. The absolute recovery of IND over this range was 93.0-113.3{\%}. The IS was stable for at least 36 h when added to plasma at ambient temperature. This method is suitable for pharmacokinetic studies of IND and has potential for monitoring therapy in infants with PDA when a target therapeutic range for IND has been validated.",
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AU - Al Za'abi, M. A.

AU - Dehghanzadeh, G. H.

AU - Norris, R. L G

AU - Charles, B. G.

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N2 - Indomethacin (IND) is the drug of choice for the closure of a patent ductus arteriosus (PDA) in neonates. This paper describes a simple, sensitive, accurate and precise microscale HPLC method suitable for the analysis of IND in plasma of premature neonates. Samples were prepared by plasma protein precipitation with acetonitrile containing the methyl ester of IND as the internal standard (IS). Chromatography was performed on a Hypersil C 18 column. The mobile phase of methanol, water and orthophosphoric acid (70:29.5:0.5, v/v, respectively), was delivered at 1.5 mL/min and monitored at 270 nm. IND and the IS were eluted at 2.9 and 4.3 min, respectively. Calibrations were linear (r > 0.999) from 25 to 2500 μg/L. The inter- and intra-day assay imprecision was less than 4.3 % at 400-2000 μg/L, and less than 22.1% at 35 μg/L. Inaccuracy ranged from -6.0% to +1.0% from 35 to 2000 μg/L. The absolute recovery of IND over this range was 93.0-113.3%. The IS was stable for at least 36 h when added to plasma at ambient temperature. This method is suitable for pharmacokinetic studies of IND and has potential for monitoring therapy in infants with PDA when a target therapeutic range for IND has been validated.

AB - Indomethacin (IND) is the drug of choice for the closure of a patent ductus arteriosus (PDA) in neonates. This paper describes a simple, sensitive, accurate and precise microscale HPLC method suitable for the analysis of IND in plasma of premature neonates. Samples were prepared by plasma protein precipitation with acetonitrile containing the methyl ester of IND as the internal standard (IS). Chromatography was performed on a Hypersil C 18 column. The mobile phase of methanol, water and orthophosphoric acid (70:29.5:0.5, v/v, respectively), was delivered at 1.5 mL/min and monitored at 270 nm. IND and the IS were eluted at 2.9 and 4.3 min, respectively. Calibrations were linear (r > 0.999) from 25 to 2500 μg/L. The inter- and intra-day assay imprecision was less than 4.3 % at 400-2000 μg/L, and less than 22.1% at 35 μg/L. Inaccuracy ranged from -6.0% to +1.0% from 35 to 2000 μg/L. The absolute recovery of IND over this range was 93.0-113.3%. The IS was stable for at least 36 h when added to plasma at ambient temperature. This method is suitable for pharmacokinetic studies of IND and has potential for monitoring therapy in infants with PDA when a target therapeutic range for IND has been validated.

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