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New validated method for piracetam HPLC determination in human plasma.

Augustin Curticapean1, Silvia Imre

  • 1University of Medicine and Pharmacy Tg-Mures, Faculty of Pharmacy, Gh. Marinescu Str. No.38, Tg-Mures RO-540139, Romania. augustin@umftgm.ro

Journal of Biochemical and Biophysical Methods
|July 18, 2006
PubMed
Summary

A new high-performance liquid chromatography (HPLC) method accurately quantifies piracetam in human plasma. This validated method is stable and suitable for bioequivalence studies of piracetam medications.

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Area of Science:

  • Analytical Chemistry
  • Pharmacokinetics

Background:

  • Piracetam is a widely used nootropic drug.
  • Accurate quantification in biological matrices is crucial for pharmacokinetic and bioequivalence studies.

Purpose of the Study:

  • To develop and validate a novel, simple, and robust HPLC method for piracetam determination in human plasma.
  • To assess the stability of piracetam under various storage conditions.

Main Methods:

  • High-performance liquid chromatography (HPLC) with UV detection at 200 nm.
  • Protein precipitation using perchloric acid.
  • RP-18 LiChroSpher 100 column with gradient elution using acetonitrile and methanol.
  • Validation included intra-day and between-days precision and accuracy assessments.

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Main Results:

  • The method achieved a lower limit of quantification (LLQ) of 2 microg/ml.
  • Intra-day and between-days assays demonstrated acceptable precision (CV% 9.7-19.1) and accuracy (bias% 0.9 to -7.45).
  • Piracetam stability was confirmed in plasma for 4 weeks at -20°C and in supernatant for 36 hours at 20°C.

Conclusions:

  • The developed HPLC method is simple, accurate, and reliable for piracetam quantification in human plasma.
  • The method's stability and validation make it suitable for bioequivalence studies of piracetam-containing drugs.