New validated method for piracetam HPLC determination in human plasma.
The new method for HPLC determination of piracetam in human plasma was developed and validated by a new approach. The simple determination by UV detection was performed on supernatant, obtained from plasma, after proteins precipitation with perchloric acid. The chromatographic separation of piracetam under a gradient elution was achieved at room temperature with a RP-18 LiChroSpher 100 column and aqueous mobile phase containing acetonitrile and methanol. The quantitative determination of piracetam was performed at 200 nm with a lower limit of quantification LLQ=2 microg/ml. For this limit, the calculated values of the coefficient of variation and difference between mean and the nominal concentration are CV%=9.7 and bias%=0.9 for the intra-day assay, and CV%=19.1 and bias%=-7.45 for the between-days assay. For precision, the range was CV%=1.8/11.6 in the intra-day and between-days assay, and for accuracy, the range was bias%=2.3/14.9 in the intra-day and between-days assay. In addition, the stability of piracetam in different conditions was verified. Piracetam proved to be stable in plasma during 4 weeks at -20 degrees C and for 36 h at 20 degrees C in the supernatant after protein precipitation. The new proposed method was used for a bioequivalence study of two medicines containing 800 mg piracetam.
Curticapean
Augustin
A
University of Medicine and Pharmacy Tg-Mures, Faculty of Pharmacy, Gh. Marinescu Str. No.38, Tg-Mures RO-540139, Romania. augustin@umftgm.ro
Imre
Silvia
S
D000097:Acetonitriles / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D006801:Humans; D000432:Methanol / Q000737:chemistry; D010889:Piracetam / Q000032:analysis / Q000097:blood*; D012680:Sensitivity and Specificity
D000097:Acetonitriles; D000432:Methanol; C032159:acetonitrile; D010889:Piracetam