Highly sensitive determination and validation of gabapentin in pharmaceutical preparations by HPLC with 4-Fluoro-7-Nitrobenzofurazan derivatization and fluorescence detection


Ulu S. T., Kel E.

Journal of Chromatographic Science, cilt.49, sa.6, ss.417-421, 2011 (SCI-Expanded) identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 49 Sayı: 6
  • Basım Tarihi: 2011
  • Doi Numarası: 10.1093/chrsci/49.6.417
  • Dergi Adı: Journal of Chromatographic Science
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Sayfa Sayıları: ss.417-421
  • İstanbul Yeni Yüzyıl Üniversitesi Adresli: Hayır

Özet

A sensitive HPLC method with pre-column fluorescence derivatization using 4-Fluoro-7-Nitrobenzofurazan (NBD-F) has been developed for the determination of gabapentin in pharmaceutical preparations. The method is based on the derivatization of gabapentin with (NBD-F) in borate buffer of pH 9.5 to yield a yellow, fluorescent product. The HPLC separation was achieved on a Inertsil C18 column (250 mm x 4.6 mm) using a mobile phase of methanol-water (80:20, v/v) solvent system at 1.2 mL/min flow rate. Mexiletine was used as the internal standard. The fluorometric detector was operated at 458 nm (excitation) and 521 nm (emission). The assay was linear over the concentration range of 5-50 ng/mL. The method was validated for specificity, linearity, limit of detection, limit of quantification, precision, accuracy, robustness. Moreover, the method was found to be sensitive with a low limit of detection (0.85 ng/mL) and limit of quantitation (2.55 ng/mL). The results of the developed procedure for gabapentin content in capsules were compared with those by the official method (USP 32). Statistical analysis by t- and F-tests, showed no significant difference at 95% confidence level between the two proposed methods.