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Pengembangan Metode Analisis secara Kromatografi pada Penetapan Kadar Simvastatin dalam Sediaan Obat

*Putri Kharisma Novita Sari  -  Prodi Farmasi, Fakultas MIPA, Universitas Sebelas Maret, Jl. Ir Sutami No.36, Jebres, Kec. Jebres, Kota Surakarta, Jawa Tengah, Indonesia 57126, Indonesia
Raihan Bintang Mahendra  -  Department Pharmacy, Faculty of Mathematic and Natural Science, Sebelas Maret University Jl. Ir. Sutami 36A, Surakarta 57126, Indonesia
Razita Fathya Usmarini  -  Department Pharmacy, Faculty of Mathematic and Natural Science, Sebelas Maret University Jl. Ir. Sutami 36A, Surakarta 57126, Indonesia
Rifqah Alya Tamimah  -  Department Pharmacy, Faculty of Mathematic and Natural Science, Sebelas Maret University Jl. Ir. Sutami 36A, Surakarta 57126, Indonesia
Lia Puspitasari  -  Department Pharmacy, Faculty of Mathematic and Natural Science, Sebelas Maret University Jl. Ir. Sutami 36A, Surakarta 57126, Indonesia
Received: 23 Dec 2024; Revised: 25 Dec 2024; Accepted: 31 Dec 2024; Available online: 16 Jan 2025; Published: 15 Jan 2025.
Open Access Copyright 2025 Generics: Journal of Research in Pharmacy

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Abstract

Simvastatin adalah obat yang bekerja dengan cara menghambat enzim HMG-CoA reduktase yang berperan penting dalam sintesis kolesterol di hati. Simvastatin tersedia dalam berbagai dosis dan dapat dikonsumsi bersama obat lain untuk menurunkan kolesterol. Analisis kadar simvastatin dalam suatu sediaan obat memerlukan metode analisis yang efektif dan tepat untuk memastikan kualitas dan keamanan dalam formulasi sediaan farmasi. Review ini bertujuan untuk menentukan kadar simvastatin pada sediaan obat dengan berbagai metode analisis secara kromatografi. Studi literatur dilakukan dengan mencari beberapa artikel jurnal penelitian internasional yang diterbitkan pada tahun 2015-2024, menggunakan kata kunci “validation methode simvastatin” “determination simvastatin” dan “determination and validation method of simvastatin”. Hasil review menunjukkan bahwa metode analisis penetapan kadar simvastatin secara kromatografi dapat dilakukan dengan High-Performance Liquid Chromatography (HPLC), Reverse-Phase HPLC (RP-HPLC), Hydrophilic Interaction Chromatography (HILIC), dan Ultra Performance Liquid Chromatography (UPLCHPLC dan RP-HPLC. Metode-metode tersebut memiliki keunggulan seperti sensitivitas, presisi, dan akurasi yang baik.

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Subject simvastatin; sediaan obat; metode analisis; kromatografi
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Keywords: simvastatin; sediaan obat; metode analisis; kromatografi

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  1. Ajay A et al. (2024) ‘Hydrophilic Interaction Liquid Chromatography (Hilic)’, Int. J. of Pharm. Sci, 2, pp. 2816–2821. Available at: https://doi.org/10.5281/zenodo.13292739
  2. Alatas, F., Sujono, H. and Sucipto, W.A. (2019) ‘PENGEMBANGAN DAN VALIDASI METODE KROMATOGRAFI CAIR KINERJA TINGGI (KCKT) UNTUK ESTIMASI KADAR SIMULTAN ANTIEMETIK PIRIDOKSIN HIDROKLORIDA DAN PIRATIAZIN TEOKLAT DALAM BENTUK SEDIAAN TABLET’, Kartika : Jurnal Ilmiah Farmasi, 6(2), p. 95. Available at: https://doi.org/10.26874/kjif.v6i2.187
  3. Alhazmi, H.A. et al. (2017) ‘A fast and validated reversed-phase HPLC method for simultaneous determination of simvastatin, atorvastatin, telmisartan and irbesartan in bulk drugs and tablet formulations’, Scientia Pharmaceutica, 86(1). Available at: https://doi.org/10.3390/scipharm86010001
  4. Belal, F. et al. (2018) ‘Development and Validation of GC-MS and HPLC Methods for the Determination of Simvastatin in Tablets and Human Urine’, Analytical Chemistry Letters, 8(5), pp. 713–726. Available at: https://doi.org/10.1080/22297928.2018.1515658
  5. Bkhaitan, M.M. (2017) ‘Simultaneous determination of simvastatin with caffeine in bulk drug, formulation and their monitoring in mice plasma through HPLC-PDA technique’, Current Analytical Chemistry, 13(6), pp. 449–455. Available at: https://doi.org/10.2174/1573411013666170721112505
  6. Clementino, A. and Sonvico, F. (2018) ‘Development and validation of a RP-HPLC method for the simultaneous detection and quantification of simvastatin’s isoforms and coenzyme Q10 in lecithin/chitosan nanoparticles’, Journal of Pharmaceutical and Biomedical Analysis, 155, pp. 33–41. Available at: https://doi.org/10.1016/j.jpba.2018.03.046
  7. Cristy, D.W.A., Harmastuti, N. and Mardiyono, M. (2024) ‘Simvastatin dengan Senyawa Turunan Β-Siklodextrin’, Journal of Telenursing (JOTING), 6(1), pp. 1259–1268. Available at: https://doi.org/10.31539/joting.v6i1.9472
  8. Desai, M.M., Apratima, A. and Nikalje, G. (2021) Quality-by-Design Based Development and Validation of Stability Indicating Method by UPLC Method for Impurities of Simvastatin from Drug and Pharmaceutical Dosage Form, Indian Journal of Pharmaceutical Sciences. Available at: www.ijpsonline.com
  9. Dewani, A.P. et al. (2015) DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF NIACIN AND SIMVASTATIN IN TABLET DOSAGE, Indian Journal of Pharmacy and Pharmacology
  10. El-Zaher A.A et al. (2019) ‘A Versatile Liquid Chromatographic Method for the Simultaneous Determination of Metformin, Sitagliptin, Simvastatin, and Ezetimibe in Different Dosage Forms’, A Versatile Liquid Chromatographic Method for the Simultaneous Determination of Metformin, Sitagliptin, Simvastatin, and Ezetimibe in Different Dosage Forms, 101(2), pp. 401–409
  11. Encarnação, T. et al. (2020) ‘Development and validation of a RP-HPLC method for the simultaneous analysis of paracetamol, ibuprofen, olanzapine, and simvastatin during microalgae bioremediation’, MethodsX, 7. Available at: https://doi.org/10.1016/j.mex.2020.101083
  12. Fahad, A.M.M., Rasheed, A.S. and Ali, H.H. (2021) ‘Separation and determination of simvastatin on ZIC-HILIC stationary phases by hydrophilic interaction chromatography in pharmaceutical material products’, in Materials Today: Proceedings. Elsevier Ltd, pp. 2817–2821. Available at: https://doi.org/10.1016/j.matpr.2021.09.535
  13. Fauziah, N.A.N., Husni, P. and Kurniati, B.D. (2023) ‘ARTIKEL REVIEW: PENGEMBANGAN DAN VALIDASI METODE ANALISIS KROMATOGRAFI CAIR KINERJA TINGGI (KCKT) UNTUK PENETAPAN KADAR SIMVASTATIN DALAM SEDIAAN TABLET’, Farmaka, 22
  14. Gumułka, P. et al. (2022) ‘UPLC Technique in Pharmacy—An Important Tool of the Modern Analyst’, Processes. MDPI. Available at: https://doi.org/10.3390/pr10122498
  15. Hsiao, C.-H. et al. (2019) ‘Development and validation of a rapid and sensitive UPLC–MS/MS assay for simultaneous quantification of paclitaxel and cyclopamine in mouse whole blood and tissue samples’, Biomedical Chromatography, 33(9), p. e4518. Available at: https://doi.org/https://doi.org/10.1002/bmc.4518
  16. Kale, R. et al. (2021) ‘Analytical method development and validation for simultaneous determination of simvastatin and mupirocin using reverse-phase high-pressure liquid chromatographic method’, Turkish Journal of Pharmaceutical Sciences, 18(4), pp. 438–444. Available at: https://doi.org/10.4274/tjps.galenos.2020.58897
  17. Kanwal, U. et al. (2021) ‘Fixed dose single tablet formulation with differential release of amlodipine besylate and simvastatin and its pharmacokinetic profile: Qbd and risk assessment approach’, Drug Design, Development and Therapy, 15, pp. 2193–2210. Available at: https://doi.org/10.2147/DDDT.S240506
  18. Kementerian Kesehatan Republik Indonesia (2020) FARMAKOPE INDONESIA EDISI VI 2020 KEMENTERIAN KESEHATAN REPUBLIK INDONESIA
  19. Kumar Basniwal, P. and Jain, D. (2012) Simvastatin: Review of Updates on Recent Trends in Pharmacokinetics, Pharmacodynamics, Drug-drug Interaction, Impurities and Analytical Methods, Current Pharmaceutical Analysis
  20. Marais, S. et al. (2019) ‘Determination of lovastatin, mevastatin, rosuvastatin and simvastatin with HPLC by means of gradient elution’, Pharmazie, 74(11), pp. 658–660. Available at: https://doi.org/10.1691/ph.2019.8192
  21. Nina Salamah and Guntarti, A. (2023) Analisis Instrumen: Kromatografi dan Elektroforesis. Edited by Nina Salamah. UAD Press
  22. Pugliano, A. et al. (2025) ‘A novel application of hydrophilic interaction liquid chromatography for the identification of compounds with intramolecular hydrogen bonds’, Journal of Pharmaceutical and Biomedical Analysis, 252. Available at: https://doi.org/10.1016/j.jpba.2024.116499
  23. Qiao, L., Shi, X. and Xu, G. (2016) ‘Recent advances in development and characterization of stationary phases for hydrophilic interaction chromatography’, TrAC - Trends in Analytical Chemistry. Elsevier B.V., pp. 23–33. Available at: https://doi.org/10.1016/j.trac.2016.03.021

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