Bioequivalence assessment of diltiazem preparations by means of discriminant analysis of data from solid-phase extraction and liquid chromatography

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Abstract

A solid-phase extraction technique for sample clean-up coupled with a new LC procedure is reported for the assay of diltiazem in plasma. The use of disposable cartridges provides selective extraction and easy automation. A new LC system based on LiChrospher® RP 60 Select B columns is described. For routine analysis, the procedure provides a rapid simultaneous clean-up of several samples prior to chromatography and reproducible recoveries over a concentration range of 10-800 ng. The procedure was used to analyse the plasma samples from a bioequivalence study of three commercial diltiazem preparations. The pharmacokinetic parameters in 12 healthy male volunteers were determined and the assessment of bioequivalence was conducted by discriminant analysis.

Original languageEnglish
Pages (from-to)941-947
Number of pages7
JournalJournal Of Pharmaceutical And Biomedical Analysis
Volume9
Issue number10-12
DOIs
Publication statusPublished - 1 Jan 1991

Fingerprint

Therapeutic Equivalency
Diltiazem
Solid Phase Extraction
Liquid chromatography
Discriminant Analysis
Discriminant analysis
Liquid Chromatography
Plasmas
Pharmacokinetics
Chromatography
Assays
Automation
Recovery
Healthy Volunteers

Keywords

  • bioequivalence
  • Diltiazem preparations
  • discriminant analysis.
  • liquid chromatography
  • solid-phase extraction

Cite this

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title = "Bioequivalence assessment of diltiazem preparations by means of discriminant analysis of data from solid-phase extraction and liquid chromatography",
abstract = "A solid-phase extraction technique for sample clean-up coupled with a new LC procedure is reported for the assay of diltiazem in plasma. The use of disposable cartridges provides selective extraction and easy automation. A new LC system based on LiChrospher{\circledR} RP 60 Select B columns is described. For routine analysis, the procedure provides a rapid simultaneous clean-up of several samples prior to chromatography and reproducible recoveries over a concentration range of 10-800 ng. The procedure was used to analyse the plasma samples from a bioequivalence study of three commercial diltiazem preparations. The pharmacokinetic parameters in 12 healthy male volunteers were determined and the assessment of bioequivalence was conducted by discriminant analysis.",
keywords = "bioequivalence, Diltiazem preparations, discriminant analysis., liquid chromatography, solid-phase extraction",
author = "{Chaves das Neves}, {Higuinaldo J.} and {Gomes da Silva}, {Marco D. R.} and Rocha, {M. P.}",
note = "The authors want to thank Instituto Luso-Farrnaco de Lisboa for the technical and financial support to this work, and to Smith Kline & French for a research grant.",
year = "1991",
month = "1",
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doi = "10.1016/0731-7085(91)80027-7",
language = "English",
volume = "9",
pages = "941--947",
journal = "Journal Of Pharmaceutical And Biomedical Analysis",
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publisher = "Elsevier Science B.V., Amsterdam.",
number = "10-12",

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TY - JOUR

T1 - Bioequivalence assessment of diltiazem preparations by means of discriminant analysis of data from solid-phase extraction and liquid chromatography

AU - Chaves das Neves, Higuinaldo J.

AU - Gomes da Silva, Marco D. R.

AU - Rocha, M. P.

N1 - The authors want to thank Instituto Luso-Farrnaco de Lisboa for the technical and financial support to this work, and to Smith Kline & French for a research grant.

PY - 1991/1/1

Y1 - 1991/1/1

N2 - A solid-phase extraction technique for sample clean-up coupled with a new LC procedure is reported for the assay of diltiazem in plasma. The use of disposable cartridges provides selective extraction and easy automation. A new LC system based on LiChrospher® RP 60 Select B columns is described. For routine analysis, the procedure provides a rapid simultaneous clean-up of several samples prior to chromatography and reproducible recoveries over a concentration range of 10-800 ng. The procedure was used to analyse the plasma samples from a bioequivalence study of three commercial diltiazem preparations. The pharmacokinetic parameters in 12 healthy male volunteers were determined and the assessment of bioequivalence was conducted by discriminant analysis.

AB - A solid-phase extraction technique for sample clean-up coupled with a new LC procedure is reported for the assay of diltiazem in plasma. The use of disposable cartridges provides selective extraction and easy automation. A new LC system based on LiChrospher® RP 60 Select B columns is described. For routine analysis, the procedure provides a rapid simultaneous clean-up of several samples prior to chromatography and reproducible recoveries over a concentration range of 10-800 ng. The procedure was used to analyse the plasma samples from a bioequivalence study of three commercial diltiazem preparations. The pharmacokinetic parameters in 12 healthy male volunteers were determined and the assessment of bioequivalence was conducted by discriminant analysis.

KW - bioequivalence

KW - Diltiazem preparations

KW - discriminant analysis.

KW - liquid chromatography

KW - solid-phase extraction

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U2 - 10.1016/0731-7085(91)80027-7

DO - 10.1016/0731-7085(91)80027-7

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VL - 9

SP - 941

EP - 947

JO - Journal Of Pharmaceutical And Biomedical Analysis

JF - Journal Of Pharmaceutical And Biomedical Analysis

SN - 0731-7085

IS - 10-12

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