PENETAPAN KADAR KLORAMFENIKOL DALAM TETES MATA PADA SEDIAAN GENERIK DAN MERK DENGAN METODE KROMATOGRAFI CAIR KINERJA TINGGI
DOI:
https://doi.org/10.30595/pji.v6i2.421Abstract
ABSTRAK Telah dilakukan penetapan kadar kloramfenikol dalam tetes mata pada sediaan generik dan merk menggunakan Kromatografi Cair Kinerja Tinggi (KCKT) fase terbalik dengan detektor ultraviolet pada panjang gelombang 280 nm. Fase diam yang digunakan adalah kolom Shimpack ODS CLC C18, fase gerak metanol:air (40:60) dengan kecepatan alir 1 mL/menit. Penentuan linearitas dengan kurva baku menunjukkan hubungan yang linier antara luas puncak dan konsentrasi baku kloramfenikol dengan konsentrasi 10-30 µg/mL (r=0,990). Persamaan regresi yang diperoleh adalah y=1,6429x- 5,5758. Nilai limit of detection (LOD) sebesar 5,2 µg/mL dan nilai limit of quantitation (LOQ) sebesar 17,3 µg/mL. Uji presisi memberikan hasil nilai koefisien variasi sebesar 5,988%. Hasil penetapan kadar kloramfenikol dalam tetes mata pada sediaan generik adalah 117,6% dan dalam tetes mata bermerek sebesar 111,29%. Berdasarkan pengujian, sampel tetes mata generik dan bermerek memenuhi persyaratan yang tertera pada Farmakope Indonesia edisi IV. Kata kunci: kloramfenikol, KCKT, tetes mata ABSTRACT Determination of Chloramphenicol in generic and branded eye drop had been carried out by reversed phase high performance liquid chromatography (HPLC) method with UV detector (280 nm). The Shimpack ODS CLC C18 column was used as stationary phase, methanol:water (40:60) v/v as mobile phase, with flow rate 1 mL/minute. Determination of calibration curve linearity showed linear correlation between the peak area and concentration at 10-30 µg/mL with correlation coefficient r=0.990. The equation of regression was y=1.6429x – 5.5758 with LOD and LOQ were 5.2 and 17.3 µg/mL respectively. The precision test showed coefficient variation (CV) was 5.988%. The average chloramphenicol content of generic and branded product were 117.6 and 111.29% respectively. The sample was fulfilled the requirement of Farmakope Indonesia fourth edition. Keywords: chloramphenicol, reversed phase HPLC, eye drop.References
Departemen Kesehatan Republik Indonesia. 1995. Farmakope Indonesia Ed. IV. Jakarta : Departemen Kesehatan Republik Indonesia.
Gunawan, I., 1994, Metode Validasi Pada Analisis Kimia, Pendidikan Kelanjutan Apoteker, Surabaya : Fakultas Farmasi Universitas Airlangga
Mulya, M. & Suharman, 1995, Analisis Instrumental, Surabaya, Airlangga University Press.
Snyder, L.R, Joseph, K., & Josephl, G. 1997. Practical HPLC Method Development Second Edition. New York USA: John and Wiley & Sons.
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Published
2009-08-01
How to Cite
Sari, F. D. P., & Utami, P. I. (2009). PENETAPAN KADAR KLORAMFENIKOL DALAM TETES MATA PADA SEDIAAN GENERIK DAN MERK DENGAN METODE KROMATOGRAFI CAIR KINERJA TINGGI. PHARMACY: Jurnal Farmasi Indonesia (Pharmaceutical Journal of Indonesia), 6(02). https://doi.org/10.30595/pji.v6i2.421
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