Repository Universitas Pakuan

Detail Karya Ilmiah Dosen

Ade Heri Mulyati, Sutanto, Dewi Apriyani

Judul : Validasi Metode Analisis Kadar Ambrokol Hidroklorida dalam Sediaan Tablet Cystelis Secara Kromatografi Cair Kinerja Tinggi
Abstrak :

Cystelis® tablet is an expectorant medicine which contain 30 mg/tablet of Ambroxol
Hydrochloride. To ensure the safety and effectiveness of the medicine must be well controlled
especially the analytical methode which used to determined the actived ingredient in the
medicine. This analytical methode must resulting the amount of Ambroxol Hydrochloride
which can be trusted. The purpose of this research are to test and proof the result of
determination Ambroxol Hydrochloride in Cystelis® tablet could be trusted in daily test in
laboratorium. Analytical methode validation is a effort to get and documented proof that the
result of test methode can be trusted with some specification. The Parameters of analytical
methode validation are precision, linearity, accuracy, range, selectivity, and stability test
(robustness). Analytical methode that used in pharmacy specially High Performance Liquid
Chromatography (HPLC), using mobile phase metanol : buffer potassium dyhidrogen
phosphate 0,01 M (70:30) pH 6,0 and stationary phase C18 Symmetry (150 mm x 4,6 mm)
with particle size 5m, flow rate 1,0 mL/minute, injection volume 10,0 L and measured at
wavelength 247 nm. Analytical results showed that the placebo did not gived any analytical
respons in selectivity test. Accuracy which know as % recovery showed the average of %
recovery 99,31% (98,70 100,44%), range between 80%-120%. Linearity at consentration
range 70% - 130% with coefficient correlacy (r) 0,99924. The result of precision which is
repeatability with average of % RSD 0,25%. Based on t value and F value on intermediate
precision showed that there is no differently result gived by the analytical methode with
different analyst and time. Stability test solution and mobile phase composition with % bias
2% and %RSD 2%. Based on the analytical methode validation result the determination
of Ambroxol Hydrochloride in Cystelis® tablet with high performace liquid chromatography
we can conclude that this analytical methode is valid to implemented in daily inspection at
Quality Control laboratory PT. Armoxindo Farma
Kata kunci : Validation, Analytical methode, Ambroxol Hydrochloride, HPLC

Tahun : 2011 Media Publikasi : Jurnal Nasional Blm Akreditasi
Kategori : Jurnal No/Vol/Tahun : 2 / 11 / 2011
ISSN/ISBN : 1411-9447
PTN/S : Universitas Pakuan Program Studi : KIMIA
Bibliography :

Badan Pengawas Obat dan Makanan. 2002.
Petunjuk Operasional Cara Pengolahan
Obat yang Baik. Jakarta.
. 2004. Pedoman Uji Bioekivalensi.
Cetakan I. Jakarta.
BP (British Pharmacopoeia). 2003. British
Pharmacopoeia. Vol. I. London: The
Stationary Office.
FDA (Food and Drug Administration). 2001.
Guidance for Industry Bioanalytical
Method Validation. Center for Drug
Evaluation and Research, Rockville,
Gritter, R. J., M. Bobbitt dan A. E. Schwarting.
1991. Pengantar Kromatografi. Edisi II.
Kosasih Padmawinata, penerjemah.
Bandung: ITB. Terjemahan dari:
Introduction to Chromatography.
ICH (International Conference
Harmonization). 1994. Note for
Guidance on Validation of Analytical
Procedurs: Definitions and Terminology,
ICH Topic Q2A. The European Agency
for the Evaluation of Medicinal Products.
ICH (International Conference
Harmonization). 1994. Note for
Ekologia, Vol. 11 No.2 , Oktober 2011: 36-45
Validasi Metode Analisis Kadar Ambroksol.…………...…..………...…. (Ade Heri Mulyati, dkk) 45
Guidance on Validation of Analytical
Procedurs, ICH Topic Q2B. The
European Agency for the Evaluation of
Medicinal Products.
Riley, C. M. and Rosanske T. W. 1996.
Development and Validation of
Analytical Methods. Vol. 3. USA:
Elsevier Science Ltd.
Synder, L. R., J. J. Kirkland and J. L. Glajch.
1997. Practical HPLC Method
Development. Second Edition. New
York: John Willey & Sons Inc.