A validated HPLC method for the determination of the neuraminidase inhibitor, zanamivir (GG167), in spiked human plasma and in pharmaceutical formulations


Erk N.

JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES, cilt.27, sa.10, ss.1541-1552, 2004 (SCI-Expanded, Scopus) identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 27 Sayı: 10
  • Basım Tarihi: 2004
  • Doi Numarası: 10.1081/jlc-120034090
  • Dergi Adı: JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Sayfa Sayıları: ss.1541-1552
  • Anahtar Kelimeler: zanamivir, indinavir, spiked human plasma, pharmaceutical formulation, validation, high performance liquid chromatography, PERFORMANCE LIQUID-CHROMATOGRAPHY, HIV PROTEASE INHIBITORS, SIMULTANEOUS QUANTITATIVE-DETERMINATION, TANDEM MASS-SPECTROMETRY, TRANSCRIPTASE INHIBITORS, ANTIRETROVIRAL AGENTS, HUMAN SERUM, INDINAVIR, RITONAVIR, SAQUINAVIR
  • Ankara Üniversitesi Adresli: Evet

Özet

A new, simple, precise, sensitive reverse phase-high performance liquid chromatographic (RP-HPLC) technique has been developed for the determination of zanamivir in spiked human plasma and its pharmaceutical formulations. The method employs acetonitrile and water (50: 50 v/v) as, mobile phase with flow rate of 1.2 mL min(-1), Supelcocil C-18 (150 x 4.6 min i.d: 5 mum particle size) column, loop of 20 muL, and UV detection at 230.0 nm. T he internal standard method using indinavir as the internal standard is used. The validation of this technique showed that it is linear in a range of 8.0-7500.0 ng mL(-1) (r: 0.9987). The limit of detection and quantitation is 0.15 ng mL(-1) (0.5%) and 0.90 ng mL(-1) (1.8%), respectively. Each analysis required no longer than 5 min. Furthermore, the typical excipients included in the pharmaceutical product do not interfere with the selectivity of the method. Finally, the proposed chromatographic method was successfully applied to the quantitative determination of the neuraminidase inhibitor zanamivir (GG167) in spiked human plasma and pharmaceutical formulation.