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Penetapan Kadar Levofloksasin Generik dan Paten Dalam Plasma Manusia Secara In Vitro Menggunakan Metode Kromatografi Cair Kinerja Tinggi

Proceeding from jhptump / 2017-11-29 12:00:06
Oleh : Pri Iswati Utami, dan Susanti, Universitas Muhammadiyah Purwokerto (
Dibuat : 2016-11-21, dengan 3 file

Keyword : HPLC, Branded and generic Levofloxacin, human plasma.

Levofloxacin, the L-isomer of ofloxacin has a broad spectrum activity and has been shown to be more active than ofloxacin. The aim of this research is to develop an analytical method to determine in vitro human plasma concentration of generic and branded levofloxacin by HPLC with Uv detector The stationary phase was Octadesyl silane (ODS) in a stainless steel column, 25 cm x 4.6 mm (5 m particle size). The mobile phase was 0.16% ortho-phosphoric acid, adjusted to pH 3 with sodium hydroxide 0.2 N : acetonitrile (85:15). Detector ultraviolet (λ 295 nm) was used. The flow rate was 1.0 ml/min. Plasma sample (475 μL) spiked with 2.5 μg Levofloxacin and 500 μl 0.16% orto-phosphoric acid was added. The mixture was vortexed, add 5 ml of isopropyl alcohol : diclormethan (1:9), and the mixture was roller mixer for 30 minute, and ultracentrifuge at 3000 rpm. Residue of 4 ml organic layer was reconstitution with mobile phase. The filtrate (20 μL) was injected in the HPLC system. The chromatogram shows good selectivity, no chromatographic peaks that could potentially interfere with that of levofloxacin. Branded and Generic Levofloxacin plasma concentration found 3.24±0.12 and 3.18±0.26 μg/ml respectively. The percentages of branded and generic recoveries were 96.36±6.98% and 95.75±15.80% respectively. The repeatability of the assay, expressed as the percentage coefficient of variation (% CV) were 3.70 and 8.36 %. The conclusion of this research that the method describes here is specific and sensitive assay for in vitro human plasma concentration of generic and branded levofloxacin

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