Repository Universitas Pakuan

Detail Karya Ilmiah Dosen

Ade Heri Mulyati, Sutanto, Dewi Apriyani

Judul : VALIDASI METODE ANALISIS KADAR AMBROKSOL HIDROKLORIDA DALAM SEDIAAN TABLET CYSTELIS SECARA KROMATOGRAFI CAIR KINERJA TINGGI ïƒ’

Abstrak :
VALIDASI METODE ANALISIS KADAR AMBROKSOL HIDROKLORIDA DALAM SEDIAAN TABLET CYSTELIS
SECARA KROMATOGRAFI CAIR KINERJA TINGGI

Ade Heri Mulyati 1); Sutanto 2);  dan Dewi Apriyani 3)
1,2,3). Program Studi Kimia, Fakultas Matematika dan Ilmu Pengetahuan Alam,  Universitas Pakuan Bogor

ABSTRACT

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 5ïm, flow rate 1,0 mL/minute, injection volume 10,0 ïL 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 ï‚£ 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

Key words : 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 :
DAFTAR PUSTAKA
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: TheStationary Office.

FDA (Food and Drug Administration). 2001.Guidance for Industry Bioanalytical Method Validation. Center for Drug Evaluation and Research, Rockville,MD, USA.

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 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.

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Detail Karya Ilmiah Dosen

Ade Heri Mulyati, Sutanto, Dewi Apriyani

Judul	:	VALIDASI METODE ANALISIS KADAR AMBROKSOL HIDROKLORIDA DALAM SEDIAAN TABLET CYSTELIS SECARA KROMATOGRAFI CAIR KINERJA TINGGI ïƒ’
Abstrak	:	VALIDASI METODE ANALISIS KADAR AMBROKSOL HIDROKLORIDA DALAM SEDIAAN TABLET CYSTELIS SECARA KROMATOGRAFI CAIR KINERJA TINGGI Ade Heri Mulyati 1); Sutanto 2); dan Dewi Apriyani 3) 1,2,3). Program Studi Kimia, Fakultas Matematika dan Ilmu Pengetahuan Alam, Universitas Pakuan Bogor ABSTRACT 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 5ïm, flow rate 1,0 mL/minute, injection volume 10,0 ïL 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 ï‚£ 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 Key words : 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	:	DAFTAR PUSTAKA 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: TheStationary Office. FDA (Food and Drug Administration). 2001.Guidance for Industry Bioanalytical Method Validation. Center for Drug Evaluation and Research, Rockville,MD, USA. 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 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.
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