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Tiwi Ambarati
Najla Yusiana Wahyudi
Saarah Hamidah Asmara Indratno
Lina Nurfadhila
Marsah Rahmawati Utami

Page: 838-847

Abstract

Paracetamol is one of the most widely used pain relievers and analgesic drugs by the public. Examination of drug concentrations in biological samples using appropriate methods is necessary to ensure drug quality and optimize drug therapy. Therefore, this literature study was conducted with the aim of determining paracetamol levels in biological samples and testing its validity with various methods. Literature research was carried out by searching for several research journal articles that had been published in 2013-2023, which were selected according to the inclusion and exclusion criteria. Six journals were obtained regarding the validation of analytical methods for determining paracetamol levels in biological samples using various methods such as Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS), Mass Spectrometry-High Performance Liquid Chromatography (HPLC- MS), and Mass Spectrometry Ultra High-Performance Liquid Chromatography (UHPLC-MS). From the above review it can be concluded that the method of analyzing paracetamol compounds in biological samples can be carried out with these four methods where the results of the analytical methods namely accuracy, selectivity, linearity, precision, LOD, and LOQ all meet the requirements or set criteria.

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How to Cite
Ambarati, T., Wahyudi, N. Y., Hamidah Asmara Indratno, S., Nurfadhila, lina, & Utami, M. R. (2023). Article Review: Validation of Analysis Methods for Determining Paracetamol Content in Biological Samples Using Various Methods. Journal of Pharmaceutical and Sciences, 6(2), 838–847. https://doi.org/10.36490/journal-jps.com.v6i2.157
Section
Review Article

References

Alegre, M., Romero, J., & Broch, S. (2012). Is it really necessary to validate an analytical method or not? That is the question. Journal of Chromatography A, 1232, 101–109. https://doi.org/10.1016/j.chroma.2011.10.050

Aprida, C. D. B., Prayuda, E. M., Odhia, F. N., Andriani, N., Nailuvar, R., & Andini, S. D. (2022). Analisis Senyawa Acetaminophen Pada Spesimen Rambut Manusia Menggunakan Metode Kromatografi Gas- Spektrometri Massa (Gc-Ms). Syntax Idea, 4(5), 861–870.

Aryasa, et al. (2018). Penentuan Kadar Parasetamol Pada Obat Dan Jamu Tradisional Menggunakan Metode Spektrofotometri Uv/Vis. Jurnal Media Sains, 2 (1), 48 – 53.

Association of Analytical Chemistry (AOAC). (2002). AOAC Requirements for Single Laboratory Validation of Chemical Methods for Dietary Supplements and Botanical. AOAC International.

Aulia, S. S., Sopyan, I., & Muchtaridi. (2016). Penetapan Kadar Simvastatin Menggunakan Kromatografi Cair Kinerja Tinggi (KCKT) :Review. Farmaka, 14(4), 70–78.

Darmapatni, K. A. G. (2016). Pengembangan Metode GC-MS untuk Penetapan Kadar Acetaminophen pada Spesimen Rambut Manusia. Jurnal Biosains Pascasarjana, 18(3), 255. https://doi.org/10.20473/jbp.v18i3.2016.255-266

Departemen Kesehatan RI. Undang-Undang Republik Indonesia Nomor 36 Tahun 2009 Tentang Kesehatan. Jakarta: Kementerian Kesehatan RI.

Depkes RI., 1995. Farmakope Indonesia, Edisi IV, Departemen Kesehatan Republik Indonesia, Jakarta.

Eurachem. (2014). The Fitness for Purpose of Analytical Method: A Laboratory Guide to Method Validation and Related Topics [Internet]. Available from:www.eurachem.org

FDA. (2018). Finding and Learning about Side Effects (Adverse Reactions). Food And Drug Administration.

Fernanda, M. and Maulidia, N. (2023). Studi Degradasi Paksa Terhadap Kadar Paracetamol Menggunakan Spektrofotometri UV-Vis. Journal Pharmasci (Journal of Pharmacy and Science), 8(1), 15-20.

Flint, R. B., Mian, P., Van Der Nagel, B., Slijkhuis, N., & Koch, B. C. P. (2017). Quantification of acetaminophen and its metabolites in plasma using UPLC-MS: Doors open to therapeutic drug monitoring in special patient populations. Therapeutic Drug Monitoring, 39(2), 164–171. https://doi.org/10.1097/FTD.0000000000000379

Fransiska et al. (2022). Analisis Senyawa Obat dalam Sampel Biologis Plasma Darah. Syntax Idea, 4(5), 905-912.

Grace Pricilia, Sudewi, S., & Lolo, W. A. (2015). Validasi Metode Analisis Untuk Penetapan Kadar Parasetamol dalam Sediaan Tablet. Pharmacon, 4(4), 168–178.

Hidayat, Agus Purwo, M Sofyan Harahap, and Yulia Wahyu Villyastuti. (2017). “Perbedaan Antara Parasetamol Dan Ketorolak terhadap Kadar Substansi P Serum Tikus Wistar Sebagai Analgesik.” Jurnal Anestesiologi Indonesia, 9(1), 12.

Hussain, S., Shaikh, T.(2014). Ultra High Performance Liquid Chromatography (UPLC): A New Trend In Analysis. World Journal of Pharmaceutical Research, 3(3), 5041–5048.

International Conferencon Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. (2005). Topic Q2 (R1) Validation of Analytical Procedures: Text and Methodology [Internet]. Available from:www.ich.org

Junior, E. J. A. G., Roeder, J. S., Oliveira, K. B. L., Goes, L. D. C., Ferreira, M. P., & Da Silva, J. G. (2018). UV Spectrophotometry Method Validation for Quantification of Paracetamol in Tablet Formulations: A Proposal of Experimental Activity for Instrumental Analysis. Orbital: The Electronic Journal of Chemistry, 10(7). https://doi.org/10.17807/orbital.v10i7.1330

Kam, R. K., Chan, M. H., Wong, H., Ghose, A., Dondorp, A. M., Plewes, K., & Tarning, J. (2018). Quantitation of paracetamol by liquid chromatography – mass spectrometry in human plasma in support of clinical trial. 4.

Khoiroh, R., Wulandari, L., & Kristiningrum, N. (2017). Pembentukan Model Kalibrasi Spektra Spektrofotometri NIR dan UV-VIS untuk Penetapan Kadar Parasetamol dalam Sirup (Formation of NIR and UV-Vis Spectrophotometric Calibration Model For Determination of Paracetamol Level In Syrup). Jurnal Eksakta Farmasi Universitas Jember (UNEJ).

Kondratova, Y., Logoyda, L., Voloshko, Y., Megeied, A, A., Kurobko, D, et al. (2017). Development and Validation of HPLC-DAD Method For the Determination of Bisoprolol In Tablet Dosage Forms. International Journal of Applied Pharmaceutics. 9(6): 54-59.

McCrae JC, Morrison EE, Maclntyre IM, Dear JW, Webb DJ. (2018). Long-Term Adverse Effect of Paracetamol: A Review. Br J Clin Pharmacol, 84, 2218–30.

Melinda Sofyani, C., Rusdiana, T., & Yohana Chaerunnisa, A. (2018). Validasi Metode Analisis Kromatografi Cair Kinerja Tinggi Untuk Penetapan Kadar Uji Disolusi Terbanding Tablet Amoksisilin. Farmaka, 16(1), 324–330.

Mohamed, D., Hegazy, M. A., Elshahed, M. S., Toubar, S. S., & Helmy, M. I. (2018). Liquid chromatography–tandem MS/MS method for simultaneous quantification of paracetamol, chlorzoxazone and aceclofenac in human plasma: An application to a clinical pharmacokinetic study. Biomedical Chromatography, 32(7). https://doi.org/10.1002/bmc.4232

Muldianah, et al. (2022). Metode Analisis Paracetamol (Acetaminophen) dalam Darah, Plasma, dan Serum Manusia. Jurnal Penelitian dan Pengabdian Masyarakat, 2(1), 1-12.

Musiam, S., & Alfian, R. (2017). Validasi Metode Spektrofotometri Uv Pada Analisis Penetapan Kadar Asam Mefenamat Dalam Sediaan Tablet Generik. Jurnal Ilmiah Ibnu Sina, 2(1), 31 - 43. https://doi.org/10.36387/jiis.v2i1.78.

Parmar, K. A., Tandel, F. B., & Rabari, D. (2015). Analytical method development and validation of desloratadine tablet. Research Journal of Pharmacy and Technology, 8(6), 693–696. https://doi.org/10.5958/0974-360X.2015.00109.2

Praditasari, A., & Saptarini, N. M. (2018). Review: Parameter Dan Metode Sampling Validasi Pembersihan Di Industri Farmasi. Farmaka, 16(2), 1–15.

Ramadhan, S. A., & Musfiroh, I. (2021). Review Artikel : Verifikasi Metode Analisis Obat. Farmaka, 19(3), 87–92.

Rappold B. A. (2022). Review of the Use of Liquid Chromatography-Tandem Mass Spectrometry in Clinical Laboratories: Part II-Operations. Annals of laboratory medicine, 42(5), 531–557. https://doi.org/10.3343/alm.2022.42.5.531

Ravisankar, P., Navya, C,N., Pravallika, D., and Sri, D, N. (2015). A Review on Step-by-Step Analytical Method Validation. IOSR Journal Of Pharmacy. 5(10): 7-19.

Riyanto. (2014). Validasi dan Verifikasi Metode Uji: Sesuai dengan ISO/IEC 17025 Laboratorium Pengujian dan Kalibrasi. Yogyakarta: Deepublish

Rosalina, V. (2018). Analisis Kadar Sediaan Parasetamol Syrup Pada Anak Terhadap Lama Penyimpanan Dan Suhu Penyimpanan. WARTA BHAKTI HUSADA MULIA: Jurnal Kesehatan, 5(1).

Sahumena, et al. (2020). Identifikasi Jamu Yang Beredar Di Kota Kendari Menggunakan Metode Spektrofotometri Uv-Vis. Journal Syifa Sciences and Clinical Research, 2(2), 65-72.

Sari, A. I. N., & Kuntari, K. (2019). Penentuan Kafein dan Parasetamol dalam Sediaan Obat Secara Simultan Menggunakan Spektrofotometer UV-Vis. IJCA (Indonesian Journal of Chemical Analysis), 2(01), 20–27. https://doi.org/10.20885/ijca.vol2.iss1.art3

Sayuthi, M. I., & Kurniawati, P. (2015). Validasi Metode Analisis Untuk Penetapan Kadar Parasetamol Dalam Sediaan Tablet Secara Spektrofotometri Ultraviolet. Pharmacon, 4(4), 190–201.

Sharma, C. and Vivek, M. (2014). Paracetamol: mechanisms and updates. Continuing Education in Anaesthesia, Critical Care & Pain, 14(4), 153-158

Skoog, D.A., and D,M. West., (1971), Principles of instrumental analysis, Holt, Rinehart and Winston, Inc., New York.

Suastika, I. G. A., Laksmiani, N. P. L., & Wirasuta, I. M. A. G. (2014). Penetapan Kadar Parasetamol Dan Tramadol Dalam Tablet Anti Nyeri Dengan Thin Layer Chromatography (Tlc)-Spektrofotodensitometri. Jurnal Farmasi Udayana, 3(1), 279842.

Sukmawati. (2018). Optimasi dan Validasi Metode Analisis Dalam Penentuan Kandungan Total Flavonoid Pada Ekstrak Daun Gedi Hijau (Abelmoscus manihot L.) yang Diukur Menggunakan Spektrofotometer UV-Vis. PHARMACON Jurnal Ilmiah Farmasi-UNSRAT, 7(3), 32–41.

Sumarno, D., & Kusumaningtyas, D. I. (2019). Penentuan Limit Deteksi Dan Limit Kuantitasi Untuk Analisis Logam Timbal (Pb) Dalam Air Tawar Menggunakan Alat Spektrofotometer Serapan Atom. Buletin Teknik Litkayasa Sumber Daya dan Penangkapan, 16(1), 7-11.

Taylor, R. R., Hoffman, K. L., Schniedewind, B., Clavijo, C., Galinkin, J. L., & Christians, U. (2013). Comparison of the quantification of acetaminophen in plasma, cerebrospinal fluid and dried blood spots using high-performance liquid chromatography–tandem mass spectrometry. Journal of pharmaceutical and biomedical analysis, 83, 1-9.

Umapathi, P., Ayyappan, J., and Quine, S, D. (2012). Quantitative Determination of Metformin Hydrochloride in Tablet Formulation Containing Crosscarmellose Sodium as Disintegrant by HPLC and UV Spectrophotometry.Tropical Journal of Pharmaceutical Research. 11(1): 107- 116

Wardhani, D. S., & Nurbayanti, I. (2017). Validasi Metode Sni 06-6989.12-2004 Pada Penetapan Kesadahan Total Dalam Air Permukaan Secara Kompleksometri. Buletin Teknik Litkayasa Akuakultur, 15(2), 57. https://doi.org/10.15578/blta.15.2.2017.57-62

Yoedistira, C. D., & Ongkowijoyo, G. N. (2021). Validasi Metode Analisis Dan Pengujian Force Degradation Study Pada Merek Dagang Yang Mengandung Paracetamol. Jurnal Ilmiah Ibnu Sina (JIIS): Ilmu Farmasi Dan Kesehatan, 6(2), 92–101. https://doi.org/10.36387/jiis.v7i1.829

Yusuf, R., Resmawan, R., & Payu, B. R. (2021). Penerapan Model Persamaan Simultan Dengan Pendekatan Two Stage Least Square Pada Kasus Inflasi Dan Nilai Tukar Rupiah Di Indonesia. Euler : Jurnal Ilmiah Matematika, Sains Dan Teknologi, 9(2), 71–84. https://doi.org/10.34312/euler.v9i2.11173.

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