Review artikel: validasi metode analisis kadar parasetamol dalam sediaan obat menggunakan berbagai instrumen
DOI:
10.29303/sjp.v6i1.502Downloads
Abstract
Paracetamol is one of the analgesic-antipyretic drugs that has been widely used by the public as a first-line treatment. The level of paracetamol in each preparation must comply with the standards set in the Indonesian Pharmacopoeia so that it is necessary to determine the level. This study aims to evaluate the validation of the analysis method for paracetamol levels in various drug preparations using three main instruments: infrared spectrophotometry (FTIR), ultraviolet spectrophotometry (UV-Vis), and high-performance liquid chromatography (HPLC). Validation was carried out based on the parameters of accuracy, precision, limit of detection (LOD), and limit of quantification (LOQ). The results showed that the three instruments met the validation requirements set by the Indonesian Pharmacopoeia, with FTIR showing the best precision (RSD 0.03%), UV-Vis having the highest accuracy (% recovery 106.95%), and HPLC having the highest sensitivity with a LOD value of 0.76 µg/mL. For the levels of paracetamol with various dosage forms and instruments, the average results obtained meet the requirements, namely between 90%-110%. Overall, these methods are effective for the analysis of paracetamol levels, providing accurate and consistent results according to pharmacopoeial standards. Based on the review results, the instrument that mostly meets all the requirements for validation of the analysis method is HPLC.
Keywords:
analysis, paracetamol, quantitative, validation, FTIR, Spektrofotometer UV-Vis, HPLCReferences
Chasanah, L., & Oktaviani, N. (2023). Gambaran Penggunaan Obat Analgesik dan Antipiretik Paracetamol di Apotek Kelapa Tiga Kota Pekalongan. ULIL ALBAB : Jurnal Ilmiah Multidisiplin, 2(5),1664–1670. https://doi.org/10.56799/jim.v2i5.1487
Chikanbanjar, N., Semwal, N., & Jyakhwa, U. (2020). Analytical Method Validation of Meloxicam and Paracetamol Tablet in Combination by HPLC Method. International Journal of Pharmaceutical Science & Innovation, 1(1): 84-94.
Depkes, RI. (2020). Farmakope Indonesia Edisi VI. Jakarta: Departemen Kesehatan Republik Indonesia.
Dwi Harmono, H. (2020). Validasi Metode Analisis Logam Merkuri (Hg) Terlarut pada Air Permukaan dengan Automatic Mercury Analyzer. Indonesian Journal Of Laboratory, 2(3).
Gandjar, I. G. dan Rohman, A., 2007, Kimia Farmasi Analisis, Pustaka Pelajar, Yogyakarta.
Jenny, J. (2021). Penetapan Kadar Parasetamol dalam Sediaan Tablet Secara Spektrofotometri Inframerah. Herbal Medicine Journal. 4(1), 22-29.
Khodijah, K., Sriwidodo, S., & Rahman Roestan. (2024). Validasi Metode Analisis Penetapan Kadar Paracetamol, Chlorphenamine Maleate, Dextromethorphan HBr, dan Phenylephrine HCl Dalam Sediaan Kaplet Secara HPLC. Medic Nutricia : Jurnal Ilmu Kesehatan, 2(4), 18–28. https://doi.org/10.5455/nutricia.v2i4.2664
Mikulić, M., Sazdanić, D., Kladar, N., Radulović, J., Conić, B. S., dan Krstonosić, M. A. (2024). Validation of HPLC-DAD method for analysis of paracetamol and potassium sorbate in liquid oral formulations and its application to forced degradation study. AK Journal.
Putra, D. D., Yety L, N., & Dhurhania, C. E. (2023). Penetapan Kadar Sediaan Tablet Kombinasi Parasetamol Dan Tramadol Dengan Metode Spektrofotometri UV Lamda Berganda. Indonesian Journal on Medical Science, 10(1), 43-49. https://doi.org/10.55181/ijms.v10i1.391
Ravisankar P, Navya CN, Pravallika D, and Sri DN. A Review on Step-by-Step Analytical Method Validation. IOSR Journal of Pharmacy. 2015; 5(10): 7-19.
Salman., Indriana, M. (2020). Determination Of Paracetamol Levels In Tablets And Oral Solutions By High-Performance Liquid Chromatography (Hplc). Journal Of Pharmaceutical And Sciences (Jps). Vol. 3(2): 106- 113.
Sayuthi, M. I., Kurniawati, P. (2017). Validasi Metode Analisis Dan Penetapan Kadar Parasetamol Dalam Sediaan Tablet Secara Spektrofotometri Uv-Visible. Prosiding Seminar Nasional Kimia FMIPA UNESA. ISBN : 978-602-0951-15-7.
Setyaningrum, L., Hidayati, S., Anggitasari, W., Purwanti, A., Mayasari, S., Usman, M. R. (2022). Validasi Metode Analisis Penetapan Kadar Parasetamol Dan Kafein Dalam Sediaan Tablet Secara Simultan Menggunakan Rp-Hplc. Jurnal Katalisator> Vol. 7(2): 323-335.
Sivakumar, W., Jensen, M., Martinez, J., Tanana, M., Duncan, N., Hoesch, R., Riva-Cambrin, J. K., Kilburg, C., Ansari, S., & House, P. A. (2018). Intravenous acetaminophen for postoperative supratentorial craniotomy pain: A prospective, randomized, double-blinded, placebo-controlled trial. Journal of Neurosurgery, 130(3),766-772. https://doi.org/10.3171/2017.10.JNS171464
Torowati, Galuh, B. N. (2014). Penentuan Nilai Limit Deteksi Dan Kuantisasi Alat Titrasi Potensiometer Untuk Analisis Uranium.No. 13/Tahun VII. ISSN 1979-2409
Tulandi, G. P., Sudewi, S., & Lolo, W. A. (2015). Validasi Metode Analisis Untuk Penetapan Kadar Parasetamol Dalam Sediaan Tablet Secara Spektrofotometri Ultraviolet. Jurnal Ilmiah Farmasi. 4(4), 168-178.
Yulyarti, T., Rifai, Y., dan Yulianty, R. (2018). Penetapan Kadar Parasetamol, Kafein Dan Propifenazon Secara Simultan Dalam Sediaan Tablet Dengan Metode Kckt. Majalah Farmasi dan Farmakologi. 22 (1)
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