VALIDASI METODE ANALISIS KROMATOGRAFI CAIR KINERJA TINGGI UNTUK PENETAPAN KADAR AMOXICILIN DALAM PLASMA SECARA IN VITRO
DOI:
https://doi.org/10.35799/pha.4.2015.8846Abstract
VALIDASI METODE ANALISIS KROMATOGRAFI CAIR KINERJA TINGGI UNTUK PENETAPAN KADAR AMOXICILIN DALAM PLASMA SECARA IN VITRO
Ni Nyoman Puspita Sari1), Fatimawali1), Max Revolta John Runtuwene2)
1)Program Studi Farmasi FMIPA UNSRAT Manado, 95115
2)Jurusan Kimia FMIPA UNSRAT Manado, 95115
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ABSTRACT
Amoxicillin was an antibiotic concentration in the blood which measly quantity so it requires the sensitive, selective, and valid methods for analysis. In this study, optimization of the analysis condition and validation of analysis methods was carried out using the HPLC system for analysis of amoxicillin in plasma levels. Chromatography system consisting of symmetry C18 column (15 cm x 4.6 mm, 5 m) with a mobile phase methanol: potassium dihydrogen phosphate buffer (10:90 v / v), pH 5. The solution was detected at a wavelength of 230 nm, the analysis was performed at a flow rate of 2.0 ml/min and the injection volume of 20 uL. In the amoxicillin solution validation showed good linearity values ​​(r = 0.9409) as well as the value of LOD 2.5 mg/mL and the LOQ of 8.36 mg/mL. This method also meets the criteria of accuracy (% diff does not exceed ± 15% except at a concentration of 3 mg / mL) and precision (intra-day and inter-day for 2 days with% RSD ≤ 15%). While the results of the analysis of amoxicillin levels in the blood by using the validation is very small because of the low bioavailability of amoxicillin.
Keywords: Amoxicillin, HPLC, Validation, Methanol, Bioavailability
ABSTRAK
Amoxicillin merupakan antibiotik yang konsentrasinya dalam darah sangat kecil sehingga diperlukan metode analisis yang sensitif, selektif, dan valid untuk analisis. Pada penelitian ini, dilakukan optimasi kondisi analisis dan validasi metode analisis menggunakan sistem KCKT untuk analisis kadar Amoxicilin dalam plasma. Sistem kromatografi terdiri dari kolom symmetry C18 (15 cm x 4,6 mm, 5 µm) dengan fase gerak methanol: buffer kalium dihidrogen fosfat (10:90 v/v), pH 5. Larutan dideteksi pada panjang gelombang 230 nm, analisis dilakukan pada laju alir 2,0 ml/menit dan volume penyuntikan 20 µL. Pada validasi larutan amoxicillin memperlihatkan nilai linearitas yang baik (r = 0,9409) serta nilai LOD 2,5 µg/mL dan LOQ 8,36 µg/mL. Metode ini juga memenuhi kriteria akurasi (% diff tidak melampaui ± 15% kecuali pada konsentrasi 3 µg/mL) dan presisi (intra hari dan inter hari selama 2 hari dengan % RSD ≤ 15%). Sedangkan hasil analisis kadar amoxicillin di dalam darah dengan menggunakan validasi tersebut sangat kecil karena bioavailabilitas amoxicillin yang rendah.
Kata kunci: Amoxicilin, KCKT, Validasi, Metanol, Bioavailabilitas
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