Vol. 9, No 1, 2011 pp. 1 - 8
DOI 10.2298/FUPCT1101001S
UDC 543.544.3 + 615.363
DEVELOPMENT AND VALIDATION OF A GAS CHROMATOGRAPHIC METHOD FOR THE ASSAY OF MEMANTINE HYDROCHLORIDE
IN PURE AND TABLET DOSAGE FORMS
K. Siddappa*, Metre Mallikarjun, Tambe Mahesh, Kote Mallikarjun, Reddy Chandrakanth
Department of Post-Graduate Studies and Research in Chemistry, Gulbarga University, Gulbarga-585106, Karnataka, India
Abstract.A gas chromatographic method has been developed and validated for the determination of memantine hydrochloride (MMT) in pure and pharmaceutical preparations. The detection was carried out using flame ionization detector. Separation was achieved on a DB-624 fused silica packed capillary column (30 m x 0.320 mm x 1.8 µm). Nitrogen was used as a carrier gas at a flow rate of 40 mL/min. The column temperature was maintained at 300 C while the temperature of injection port and detector were maintained at 270 and 300 C, respectively. Gabapentin (GPN) was used as an internal standard. The procedure gave a linear response over the concentration range of 0.5-3.5 mg/mL with sufficient reproducibility. The method has been applied successfully for the determination of MMT in pure and pharmaceutical formulations. The excipients present in the formulations did not interfere with the assay procedure. The recovery values were found to be in the range of 99.85-100.1% with RSD values less than 1%. The results obtained from this method were compared with the reference method (HPTLC) reported in literature and no significant difference was found statistically.
Key words: gas chromatography, memantine hydrochloride, pharmaceutical dosage forms
RAZVIJANJE I VALIDACIJA GASNO-HROMATOGRAFSKE METODE ZA ODREĐIVANJE MEMANTIN-HIDROHLORIDA U ČISTOM OBLIKU I TABLETAMA
Razvijena je i validirana gasno-hromatografska (GC) metoda za određivanje memantin hidrohlorida (MMT) u čistom obliku i farmaceutskim preparatima. Detekcija je vršena korišćenjem plameno-jonizujućeg detektora. GC razdvajanje je vršeno na kapilarnoj koloni DB-625 (30 m 0.320 mm, debljina filma 80 µm). Kao noseći gas korišćen je azot, čiji je konstantni protok održavan na 40 ml/min. Temperature injektora i detektora su održavane na 270 °C i 300 °C, dok je temperatura kolone bila 300 °C. Gabapentin (GBN) je korišćen kao interni standard. Metoda je dala linearni odziv u opsegu koncentracija od 0,5 do 3,5 mg/mL sa zadovoljavajućom reproduktivnošću i uspešno je primenjena za određivanje MMT i u čistom obliku i u farmaceutskim formulacijama. Utvrđeno je da pomoćne supstance u famaceutskim formulacijama ne smetaju pri određivanju MMT ovom metodom. Nađeno je da je rikaveri u opsegu od 99,85 do 100,1% sa RSD vrednostima manjim od 1%. Poređenjem rezultata dobijenih ovom metodom sa rezultatima referentne metode (HPTLC) nađeno je da među njima nema statistički značajne razlike.
Ključne reči: gasna hromatografija, memantin hidrohlorid, farmaceutske formulaacije
