Naslov
Folic acid tablets: dissolution – method development and validation

Autori
Kamhi, Silvia ; Štanfel, Danijela ; Lovrić Lana

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, znanstveni

Skup
Četvrti hrvatski kongres farmacije

Mjesto i datum
Opatija, Hrvatska, 27.05.2010. - 30.05.2010

Vrsta sudjelovanja
Poster

Vrsta recenzije
Domaća recenzija

Ključne riječi
folna kiselina; tablete; otpuštanje
(folic acid; tablet; dissolution)

Sažetak
Method for dissolving folic acid tablets is described in the United Stated Pharmacopoeia (USP). Water is used as a dissolution medium, although the folic acid is practically insoluble in it. Another disadvantage in using water is poor stability of its pH. For these reasons, other mediums have been researched. As a result another simple and rapid method for determination of dissolved folic acid in tablets has been developed and validated. A volume of 900 ml of phosphate buffer, pH 6.0, was used as the medium for a time of analysis of 45 minutes. As dissolution apparatus, Varian VK 7010 ; paddle (USP Apparatus 2) and Erweka DT6 ; paddle (USP Apparatus 2) were used. Rotational speed was set to 50 RPM and the temperature to 37°C ± 0, 5°C. HPLC analysis of dissolution samples was carried out on a Hypersil ODS column (250mm x 4.6mm i.d., 5 m particle size, guard column 4x4 mm). The UV detector was set to a wavelength of 282 nm. The dissolution method has been validated with satisfactory linearity (R2 = min 0, 98), range (50% to 120% ; 0.0027 mg/ml to 0.0067 mg/ml), accuracy (95% - 105% ; RSD max. 5.0%), precision and robustness. The method validation results indicate that the developed method for dissolution test of the folic acid in Folic acid 5 mg tablets is suitable for its intended use.

Izvorni jezik
Engleski

Znanstvena područja
Kemija, Farmacija

POVEZANOST RADA