VALIDASI METODE UNTUK PENETAPAN KADAR CIPROFLOXACIN DALAM SEDIAAN TABLET DENGAN NAMA DAGANG DAN GENERIK SECARA SPEKTROFOTOMETRI ULTRAVIOLET

Authors

  • Herlinda I.P. Tjaboali

DOI:

https://doi.org/10.35799/pha.4.2015.10217

Abstract

VALIDASI METODE UNTUK PENETAPAN KADAR CIPROFLOXACIN DALAM SEDIAAN TABLET DENGAN NAMA DAGANG DAN GENERIK SECARA SPEKTROFOTOMETRI ULTRAVIOLET

Herlinda I.P Tjaboali1), Fatimawali1), Defny S. Wewengkang1)

1)Program Studi Farmasi Fakultas MIPA UNSRAT Manado

ABSTRACT

Ciprofloxacin is anantibiotic from fluoroquinolon group which is the most widely used. Nowadays people prefer branded drugs than generic drugs. They assume that branded drugs were more effective than generic drugs. Eventhough drugs with the same active content will give same therapeutic effect. This research aims to determine validation and levels of ciprofloxacin tablet by UV spectrophotometry and comparing the results with levels regulation by USP30. The determination of ciprofloxacin in tablet preparation were tested its validation according to accuracy parameter used standard addition method, presisition, limits of detection and limits of quantitative. The validation with analysis method obtained standard deviation value is 13.3931, coefficient of variation is 0.0258%, and value accuracy is 96.1%. The linearity value was obtain r = 0,9978 with limits of detection is 0.54 ppm and limits of quantitative is 1.8 ppm. The results showed that ciprofloxacin levels in tablet preparation with trade name and generic were 929 ± 0,758 ppm, 1,030 ± 0,004 ppm, 947,3 ± 0,773 ppm and6,63 ± 0,994 ppm . It showed that all the trade name and generic tablets that examined fulfill the standard regulation of tablets byUSP30.

Key words : Ciprofloxacin, Validation, Ultraviolet Spectrophotometry.

ABSTRAK

Ciprofloxacin merupakan antibiotik yang berasal dari golongan fluorokuinolon yang paling banyak digunakan. Saat ini masyarakat lebih memilih obat merek dagang dibandingkan obat generik. Mereka menganggap obat merek lebih berkhasiat dibanding obat generik. Padahal obat dengan zat aktif yang sama akan memberikan efek terapi yang sama sesuai kadarnya. Tujuan penelitian ini untuk menentukan validitas dan melakukan penetapan kadar Ciprofloxacin dalam sediaan tablet secara spektrofotometri UV serta membandingkan hasil yang diperoleh dengan persyaratan kadar yang ditetapkan USP 30 (2007). Penetapan kadar Ciprofloxacin dalam sediaan tablet diuji validitasnya berdasarkan parameter akurasi dengan metode penambahan baku, presisi, batas deteksi (LOD) dan batas kuantitatif (LOQ). Hasil validasi metode analisis yang dilakukan diperoleh nilai standar deviasi (SD) sebesar 13,3931, koefisien variasi (KV) sebesar 0,0258%, dan nilai ketepatan sebesar 96,1%. Diperoleh nilai linearitas sebesar r = 0,9978 dengan batas deteksi (LOD) 0,54 ppm dan batas kuantitatif (LOQ) sebesar 1,8 ppm. Hasil penelitian menunjukkan kadar Ciprofloxacin dalam sediaan tablet dengan nama dagang dan generik secara berturut-turut adalah 929 ± 0,758 ppm, 1,030 ± 0,004 ppm, 947,3 ± 0,773 ppm dan 6,63 ± 0,994 ppm. Ini menunjukkan bahwa semua tablet yang diperiksa baik yang generik maupun merek dagang memenuhi standar persyaratan tablet menurut USP 30 (2007).

 

 

Kata kunci : Ciprofloxacin, Validasi, Spektrofotometri Ultraviolet

 

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Published

2015-11-09

How to Cite

Tjaboali, H. I. (2015). VALIDASI METODE UNTUK PENETAPAN KADAR CIPROFLOXACIN DALAM SEDIAAN TABLET DENGAN NAMA DAGANG DAN GENERIK SECARA SPEKTROFOTOMETRI ULTRAVIOLET. PHARMACON, 4(4). https://doi.org/10.35799/pha.4.2015.10217

Issue

Vol. 4 No. 4 (2015): Pharmacon

Section

Articles

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