Penentapan Kadar Tablet Siproheptadin Hidroklorida dengan Metode HPLC-PDA.
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Dhea Aulya Hidayah, Andi Suhendi, Ahmad Fauzi (2026). Penentapan Kadar Tablet Siproheptadin Hidroklorida dengan Metode HPLC-PDA.. Journal of Pharmaceutical and Sciences, JPS Volume 9 Nomor 4 (2026). https://doi.org/10.36490/journal-jps.com.v9i4.1850
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Siproheptadin hidroklorida merupakan obat antihistamin yang banyak digunakan dalam pengobatan kondisi alergi dan memerlukan evaluasi pengendalian mutu yang komprehensif untuk memastikan ketepatan, konsistensi, serta keamanan kandungan zat aktif dalam sediaan tablet. Penelitian ini bertujuan untuk melakukan verifikasi metode High Performance Liquid Chromatography (HPLC) serta menentukan kadar dan keseragaman kandungan siproheptadin hidroklorida pada beberapa produk tablet komersial. Analisis dilakukan menggunakan sistem HPLC yang dilengkapi dengan kolom C18, fase gerak berupa campuran asetonitril dan asam asetat 0,1% (60:40), serta detektor Photodiode Array (PDA) pada panjang gelombang 285 nm. Verifikasi metode dilakukan berdasarkan parameter kesesuaian sistem, presisi metode, dan akurasi. Hasil penelitian menunjukkan bahwa metode analisis memenuhi persyaratan analitik, dengan nilai koefisien korelasi >0,98, nilai presisi metode (%RSD) sebesar 1,47%, serta nilai persen perolehan kembali (%recovery) sebesar 99,51%. Penetapan kadar terhadap lima merek tablet siproheptadin hidroklorida dosis 4 mg menunjukkan rata-rata kadar berkisar antara 98,6–103,3% dengan SD antara 1,61-1,95, yang memenuhi persyaratan Farmakope Indonesia Edisi Keenam (90–110%). Selain itu, hasil uji keseragaman kandungan menunjukkan nilai Acceptance Value (AV) berkisar antara 4,05–8,06 yang memenuhi persyaratan nilai L1<15,0, sehingga seluruh sampel memenuhi persyaratan yang ditetapkan. Dengan demikian, metode HPLC-PDA yang telah diverifikasi dapat diterapkan secara andal untuk analisis kuantitatif siproheptadin hidroklorida dalam sediaan tablet. Hasil penelitian ini menunjukkan bahwa seluruh produk tablet komersial yang diuji memiliki mutu farmasi yang konsisten dan sesuai dengan standar kualitas yang berlaku
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Referensi
[1] World Health Organization. WHO good manufacturing practices for pharmaceutical products: main principles. 2014.
[2] Aman A, Hasen G, Usman H, Suleman S. Regulatory Compliance and Associated Quality of Amoxicillin in Drug Retail Outlets of Southwestern Regulatory Compliance and Associated Quality of Amoxicillin in Drug Retail Outlets of Southwestern Ethiopia 2021;1365:1–10. https://doi.org/10.2147/DHPS.S337791.
[3] Kementrian Kesehatan Republik Indonesia. Farmakope Indonesia Edisi VI. Jakarta: Kementerian Kesehatan Republik Indonesia; 2020.
[4] Jeber JN, Turkey N. A turbidimetric method for the quantitative determination of cyproheptadine hydrochloride in tablets using an optoelectronic detector based on the LEDs array. Int J Pharm Pharm Sci 2020:1–15. https://doi.org/10.31838/ijpr/2020.12.04.401.
[5] Rajput SJ, Sathe MA. New Bioanalytical HPLC Method for the Determination of Cyproheptadine Hydrochloride in Human Plasma and its Application to Rat Pharmacokinetic Study. Indian J Pharm Educ Res 2019;53:1–9. https://doi.org/10.5530/ijper.53.3s.104.
[6] Bertrand V, Massy N, Vegas N, Gras V, Chalouhi C, Tavolacci MP, et al. Safety of Cyproheptadine, an Orexigenic Drug. Analysis of the French National Pharmacovigilance Data-Base and Systematic Review. Front Pediatr 2021;9:1–14. https://doi.org/10.3389/fped.2021.712413.
[7] Constantinescu IC, Nedelcu A, Florea M, Ionescu AA, Arama CC. Extractive Spectrophotometric Methods for the Assay of Cyproheptadine Hydrochloride Using Alizarin Reds 2021;66:367–73. https://doi.org/10.33224/rrch.2021.66.4.08.
[8] Sadaphal P, Dhamak K. Review article on High-Performance Liquid Chromatography (HPLC) Method Development and Validation. Int J Pharm Sci Rev Res 2022;74:23–9. https://doi.org/10.47583/ijpsrr.2022.v74i02.003.
[9] Shasho H, Alhaj A, Trefi S. Separation and Assay of Four Antihistamine Drugs Diphenhydramine, Chlorpheniramine, Cyproheptadine and Fexofenadine in Pharmaceutical Forms by a Single HPLC Method. Int J Pharm Pharm Sci 2018;10:1–8.
[10] El-din MKS, Belal F, Tolba MM, Elmansi H. Stability indicating HPLC Method Coupled with Fluorescence Detection for the Determination of Cyproheptadine Hydro-chloride in Its Tablets . Studies on Degradation Kinetics 2018;7928:565–77. https://doi.org/10.1080/22297928.2018.1451366.
[11] Abdelrahman MM, Abdelaleem EA, Ali NW, Emam RA. Development and Validation of Stability Indicating High-Performance Liquid Chromatographic Method for Determination of Cyproheptadine Hydrochloride , its Impurity And Degradation Product. J Chromatogr Sci 2020;00:1–6. https://doi.org/10.1093/chromsci/bmaa085.
[12] Ermer J. Method Validation in Pharmaceutical Analysis Edited by Related Titles from Wiley-VCH : LC / MS Applications in Drug Development Reference Materials for Chemical Analysis. 2005.
[13] World Health Organization. Guidlines on Validation- Appendix 4 Analytical Method Validation. 2016.
[14] United States Pharmacopeia. Validation of Compendial Procedures. USP 47-NF 42 2024:1–6.
[15] Suhendi A, Ramly EA. Validasi metode analisis kapsul rifampisin dengan hplc-pda 2021;8:31–6. https://doi.org/10.22236/farmasains.v8i1.5602.
[16] Epshtein NA. Structure of Chemical Compounds, Methods of Analysis and Process Control. Pharm Chem J 2020;54:518–25. https://doi.org/10.1007/s11094-020-02231-w.
[17] Salman Umar S& HL. Validasi Metoda Analisis Penetapan Kadar Ketoprofen pada Tablet Salut Enterik secara Kromatografi Cair Kinerja Tinggi dan Spektrofotometri UV. J Sains Farm Klin 2021:200–7. https://doi.org/10.25077/jsfk.8.2.200-207.2021.
[18] Dadhich B, Goyal R, Agarwal D. A Review On: Development and Validation of HPLC in Pharmaceutical Dosage Form. Asian J Pharm Res Dev Open Access to Pharm Med Res © 2020;8:110–21.
[19] Isnaeni N, Nopi S. Validasi Metode Analisis Penetapan Kadar Bahan Baku Lapatinib Ditosylate secara KCKT-DAD 2023;4:33–42.
[20] Moosavi SM, Ghassabian S. Linearity of Calibration Curves for Analytical Methods : A Review of Criteria for Assessment of Method Reliability n.d. https://doi.org/10.5772/intechopen.72932.
[21] Ermer J. ICH Q2(R2): Validation of analytical procedures. Method Valid Pharm Anal A Guid to Best Pract Third Ed 2022;2:1–38. https://doi.org/10.1002/9783527831708.ch13.
[22] Chowdary L, Kumar A, Babu S, Analysis P. Analytical Method Validation Parameters: An Updated Review Lavanya. Int J Pharm Sci Rev Res 2020;61:1–7.
[23] Yulyarti E, Rifai Y, Yulianty R. Penetapan Kadar Parasetamol, Kafein dan Propifenazon secara Simultan dalam Sediaan Tablet dengan Metode KCKT. Maj Farm Dan Farmakol 2018;22:1–4.