Development and Validation of TLC-Densitometric Method for Analysis of Paracetamol, Mefenamic Acid and Ibuprofen simultaneously in “Pegel Linu” Traditional Medicines

Main Article Content

Hayun Hayun
Mulia Ade Karina

Abstract

Jamu is a traditional or herbal medicine that is widely used by Indonesian people for prevention, maintenance and treatment of diseases. Traditional medicines contain plants or extracted plant material, or combinations thereof. The adulteration practice violates the laws. However, the presence of undeclare synthetic chemical drugs in the herbal products are still often found, among others, analgesic and anti-inflammatory drugs. The purpose of this study is to obtain a validated, simpler and lower operational cost of TLC-densitometric method to analyze paracetamol, mefenamic acid and ibuprofen in herbal medicines in “pegel linu†herbal medicines. The samples were extracted with ethanol, then separated over silica gel GF254 TLC plate with mixture of chloroform-ethanol (8:1) as mobile phase and analyzed using TLC-densitometry. The method has a satisfactorily specificity and linearity, and met the precision and accuracy criteria at the concentration of 1500 ng/spot for paracetamol, 1250 ng/spot for mefenamic acid, and 2000 ng/spot for ibuprofen. The results of the determination of eight samples showed that four of them were positive containing paracetamol with the concentration of  337.12 - 505.55 mg/single dosage.

Article Details

How to Cite
Hayun, H., & Karina, M. A. (2016). Development and Validation of TLC-Densitometric Method for Analysis of Paracetamol, Mefenamic Acid and Ibuprofen simultaneously in “Pegel Linu” Traditional Medicines. Jurnal Sains Farmasi & Klinis, 2(2), 150–161. https://doi.org/10.29208/jsfk.2016.2.2.71
Section
Research Articles

References

Kementerian Kesehatan RI (2012). Peraturan Menteri Kesehatan Republik Indonesia Nomor 006/2012 tentang Industri dan Usaha Obat Tradisional. Kementerian Kesehatan RI, Jakarta.

Sari, L. O. (2006). Pemanfaatan Obat Tradisional dengan Pertimbangan Manfaat dan Kemanannya. Majalah Ilmu Kefarmasian, Vol. III, No.1, pp. 01-07. Depok: Departemen Farmasi FMIPA UI.

Mikail, B. (2011). Health. Obat Tradisonal Berbahaya. Kompas.com. https://health.kompas.com/read/2011/10/05/16131040/21.Obat Tradisional Ini Berbahaya. Diunduh tgl 30 Juli 2012.

Badan Pengawas Obat dan Makanan (BPOM) RI. (2014). Hasil Pengawasan Obat Tradisional Mengandung Bahan Kimia Obat. https://www.pom.go.id/new/index.php/view/pers/242/Hasil-Pengawasan--Obat-Tradisional-Mengandung-Bahan-Kimia-Obat.html

Lemke, T.L., Williams, D.A., Roche, V.F. and Zito, S.W. (2013). Foye’s Principles of Medicinal Chemistry, 7th Ed. Lippincott, Williams & Wilkins, Baltimore.

Pharmceutical Society of Australia. (2014). Obat bebas (OTC) di Apotek-panduan, saran dan terapi. The Pharmaceutical Society of Australia, Canberra.

Haneef, J.; Shaharyar, M., Husain, A., Rashid, M., Mishra, R., Siddiqueb, N.A. and Pal, M. (2013). Analytical methods for the detection of undeclared synthetic drugs in traditional herbal medicines as adulterants. Drug Test. Analysis, 5, 607–613

Adamovics, JA. and Eschbach, JC. (1997), Planar Chromatography, in Chromatographic Analysis of Pharmaceuticals, (Edited by Adamovics, JA), Marcel Dekker, New York.

Capres, S. (2005). Development of methods for analysis of synthetic adulterants in herbal medicines by HPTLC. Diploma Thesis. Institut für Pharmazeutische Biologie, Departement Pharmazeutische Wissenschaften, Philosophisch-Naturwissenschaftliche Fakultät, Universität Basel

ICH guidelines (2005). International Conference on Harmonisation Guidelines on Validation of Analytical Procedure: Text and Methodology Q2 (R1), Geneva, 1-8.

Food and Drug Administration. (1994). Validation of chromatographic methods. Reviewer guidance. September 7, 2012. https://www.fda.gov/downloads/