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October 31, 2023
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March 22, 2024
Published
May 2, 2024
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Abstract

Quality control of phytopharmaceutical products becomes a priority because they are included in the National Health Insurance. Quality control is carried out through active compound determination in the product. Currently, testing methods for active compounds are in herbs or plant extracts, but none for products. Phytopharmaceutical products for cardiovascular system therapy class contain Apii graveolentis herba and Orthosiphomis staminei folium extracts. The research aims to develop analytical methods that are selective, accurate and reliable to assay the active compounds of sinensetin in product contains Apii graveolentis herba extract by TLC and apigenin in product contains Orthosiphomis staminei folium extract by LC-MS/MS. From the results, it is proven that both methods are valid and reliable with linearity, precision and accuracy values that meet the requirements. The linearity of sinensetin and apigenin has correlation coefficient values of 0.9972 and 0.9995, with residual deviation values (Vx0) of 4.0% and 1.7%. Good repeatability is represented by the low number of precision values. Sinensetin precision at a concentration of 91.83; 310.33; and 586.68 µg/g were 1.11; 0.61; and 1.50%, while the apigenin precision at a concentration of 5; 15; and 25 µg/g were 5.82; 4.36; and 2.32% respectively. Accuracy of sinensetin at a concentration of 100.24; 300.72; and 601.44 µg/g were 90.8 - 92.7%; 102.5 - 103.7%; and 96.5 - 99.2%, while the accuracy of apigenin at a concentration of 5; 15; and 25 µg/g were 81.58 - 91.57%; 86.71 - 93.76%; and 89.12 - 93.31 % respectively. The developed methods were sensitive with the limit of quantitation (LoQ) values for sinensetin and apigenin were 3.34 ng/g and 6.67 µg/g. The validated methods can be applied to determine sinensetin and apigenin in cardiovascular system therapy class phytopharmaceutical products.

Keywords

apigenin marker compounds phytopharmaceutical product sinensetin apigenin produk fitofarmaka senyawa penanda sinensetin

Article Details

How to Cite
Kurniawati, F., Risma Uli, A., & Bodrorini, . N. (2024). Marker Analysis as Phytopharmaceutical Products Quality Control: A Case Study on Phytopharmaceutical Products of Cardiovascular Therapy Class. Eruditio : Indonesia Journal of Food and Drug Safety, 4(1), 51–62. https://doi.org/10.54384/eruditio.v4i1.185
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References

  1. Ambrin, G., Ali, H. M., & Ahmad, A. (2020). Metabolic regulation analysis of ajmalicine biosynthesis pathway in Catharanthus roseus (L.) G. Don suspension culture using nanosensor. Processes, 8(5), 1–12. https://doi.org/10.3390/PR8050589
  2. Badan Pengawas Obat dan Makanan. (2020). Peraturan Badan Pengawas Obat Dan Makanan Nomor 9 Tahun 2020 Tentang Rencana Strategis Badan Pengawas Obat Dan Makanan Tahun 2020-2024. Badan Pengawas Obat Dan Makanan, 88, 1–155.
  3. BPOM RI. (2004). Keputusan Kepala Badan Pengawas Obat dan Makanan Republik Indonesia Nomor HK. 00.05.4.2411 Tentang Ketentuan Pokok Pengelompokan dan Penandaan Obat Bahan Alam Indonesia.
  4. BPOM RI. (2019). Persyaratan Keamanan Dan Mutu Obat Tradisional. Bpom RI, 32, 37.
  5. Control, Q., & Medicines, H. (2022). Validated Spectroscopic and Chromatographic Techniques for Quality. 13(12), 4857–4864. https://doi.org/10.13040/IJPSR.0975-8232.13(12).4857-64
  6. Ismail. (2015). Faktor yang Mempengaruhi Keputusan Masyarakat Memilih Obat Tradisional di Gampong Lam Ujong. Idea Nursing Journal, VI(1), 7–14.
  7. Jewell, K. S., Kunkel, U., Ehlig, B., Thron, F., Schlüsener, M., Dietrich, C., Wick, A., & Ternes, T. A. (2020). Comparing mass, retention time and tandem mass spectra as criteria for the automated screening of small molecules in aqueous environmental samples analyzed by liquid chromatography/quadrupole time-of-flight tandem mass spectrometry. Rapid Communications in Mass Spectrometry, 34(1), 1–9. https://doi.org/10.1002/rcm.8541
  8. Karaźniewicz-Łada, M., Wójtowski, J. A., Główka, F., Danków, R., Pikul, J., Gryszczyńska, A., Foksowicz-Flaczyk, J., & Mikołajczak, P. Ł. (2023). Application of UPLC-MS/MS Method for Analysis of Apigenin, Apigenin 7-Glucoside and Chlorogenic Acid in Goat Serum. Chromatographia, 86(5), 401–411. https://doi.org/10.1007/s10337-023-04250-7
  9. Kartini, K., Putri, R. E., & Budiono, R. (2023). Quantification of sinensetin in Orthosiphon stamineus from various phytogeographical zones in Indonesia. Journal of Applied Pharmaceutical Science, 13(3), 183–191. https://doi.org/10.7324/JAPS.2023.80035
  10. Kementerian Kesehatan Republik Indonesia. (2017). Farmakope Herbal Indonesia (II).
  11. Kementerian Kesehatan RI. (2022). Formularium Fitofarmaka.
  12. Lu, S., Tran, B. N., Nelsen, J. L., & Aldous, K. M. (2009). Quantitative analysis of mitragynine in human urine by high performance liquid chromatography-tandem mass spectrometry. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 877(24), 2499–2505. https://doi.org/10.1016/j.jchromb.2009.06.024
  13. Miller, J. M., & Crowther, J. B. (2000). Analytical chemistry in a GMP environment: a practical guide.
  14. Muhamad, S. (2023). Kemenkes dorong penggunaan fitofarmaka ditanggung BPJS Kesehatan. Antara. https://www.antaranews.com/berita/3759291/kemenkes-dorong-penggunaan-fitofarmaka-ditanggung-bpjs-kesehatan
  15. Nooreen, Z., Rai, V. K., & Yadav, N. P. (2018). Phytopharmaceuticals: A new class of drug in India. Annals of Phytomedicine: An International Journal, 7(1). https://doi.org/10.21276/ap.2018.7.1.4
  16. Panchal, H., & Shah, M. (2017). Development of Simultaneous LC – MS / MS Method for the Quantitation of Apigenin, Luteolin and Quercetin in Achillea millefolium Extract. Der Pharmacia Lettre, 9(12), 72–86.
  17. Pramono, E. S. (2004). Isolasi identifikasi dan standarisasi sinensetin sebagai parameter pada ekstrak daun Kumis Kucing (Orthosiphon stamineus, Benth.). Universitas Gadjah Mada, Yogyakarta.
  18. Pusat Pengembangan Pengujian Obat dan Makanan Nasional. (2023a). Identifikasi dan Penetapan Kadar Apigenin dalam Produk Fitofarmaka secara Kromatografi Cair Kinerja Tinggi-Tandem Spektrometri Massa.
  19. Pusat Pengembangan Pengujian Obat dan Makanan Nasional. (2023b). Identifikasi dan Penetapan Kadar Sinensetin dalam Produk Fitofarmaka secara Kromatografi Lapis Tipis-Spektrofotodensitometri.
  20. Saidan, N. H., Hamil, M. S. R., Memon, A. H., Abdelbari, M. M., Hamdan, M. R., Mohd, K. S., Majid, A. M. S. A., & Ismail, Z. (2015). Selected metabolites profiling of Orthosiphon stamineus Benth leaves extracts combined with chemometrics analysis and correlation with biological activities. BMC Complementary and Alternative Medicine, 15(1), 1–13. https://doi.org/10.1186/s12906-015-0884-0
  21. Shakeel, F., Alshehri, S., Ibrahim, M. A., Elzayat, E. M., Altamimi, M. A., Mohsin, K., Alanazi, F. K., & Alsarra, I. A. (2017). Solubility and thermodynamic parameters of apigenin in different neat solvents at different temperatures. Journal of Molecular Liquids, 234, 73–80. https://doi.org/10.1016/j.molliq.2017.03.057
  22. Wieling, J. (2002). LC-MS-MS experiences with internal standards. Chromatographia, 55(SUPPL.). https://doi.org/10.1007/bf02493365
  23. Xu, Q. A., & Madden, T. L. (2012). LC-MS in drug bioanalysis. In LC-MS in Drug Bioanalysis (Vol. 9781461438). https://doi.org/10.1007/978-1-4614-3828-1
  24. Yuwono, M., & Indrayanto, G. (2005). Validation of Chromatographic Methods of Analysis. Profiles of Drug Substances, Excipients and Related Methodology, 32(05), 241–260. https://doi.org/10.1016/S0099-5428(05)32009-0