Validasi Metode Analisis Kapsul Rifampisin Dengan HPLC-PDA
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Issue
Vol. 8 No. 1 (2021)
Submitted
September 14, 2020
Published
April 29, 2021
Keywords:
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HPLC, Method Validation, Rifampicin RP-HPLC, Validasi Metode, Rifampisin
Abstract
Rifampisin merupakan salah satu obat anti-tuberkulosis. HPLC merupakan metode pilihan karena kepekaan, reprodusibilitas dan spesifitasnya. Namun metode terbaru dari kromatografi cair membutuhkan penambahan tetra-butyl ammonium hydroxide yang dapat memperpendek umur kolom. Penelitian ini bertujuan untuk mengembangkan suatu metode kromatografi cair dengan waktu pengerjaan yang efisien dibandingkan metode-metode sebelumnya. Sistem kromatografi yaitu HPLC Alliance 2695, C18 (100 x 4,6 mm; 5 µm), fase gerak sistem gradient berupa asetonitril dan akuades dengan laju alir 1,0 mL/menit dan dideteksi pada 254 nm. Hasil penetapan parameter validasi didapatkan bahwa metode akurat dengan %recovery 99,96 ± 0,04% dan RSD 0,64 ± 0,30%. Parameter linieritas didapatkan koefisien korelasi 0,998, kerberulangan dan presisi antara didapatkan RSD masing-masing yaitu 1,51% dan 1,54%. Nilai LoQ didapatkan dari persamaan regresi linier residual yaitu 0,0164%. Metode yang divalidasi memenuhi parameter validasi akurasi, presisi dan linieritas.
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References
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Benetton, S.A., Kedor-Hackmann, E.R., Santoro, M.I., Borges, V.M., 1998. Visible spectrophotometric and first-derivative UV spectrophotometric determination of rifampicin and isoniazid in pharmaceutical preparations. Talanta 47, 639–643.
Brunton, L., Knollmann, B., Hilal-Dandan, R., 2017. Goodman and Gilman's The Pharmacological Basis of Therapeutics, 13th Edition, 13th Edition. ed. McGraw-Hill Education / Medical, New York.
Calleri, E., De Lorenzi, E., Massolini, G., Caccialanza, G., Furlanetto, S., 2002. Validation of a RP-LC method for the simultaneous determination of isoniazid, pyrazinamide and rifampicin in a pharmaceutical formulation. J. Pharm. Biomed. Anal. 29, 1089–1096.
Departemen Kesehatan Republik Indonesia, 2014. Farmakope Indonesia, Edisi V. ed. Jakarta.
Dolan, J., 2006. HPLC Columns John Dolan A Guide to HPLC and LC-MS Buffer Selection [WWW Document]. URL /paper/HPLC-Columns-John-Dolan-A-Guide-to-HPLC-and-LC-MS-Dolan/078e716132ea3bc0e1663205ef160225c4e234e6 (accessed 10.13.20).
Dolan, J., n.d. HPLC Columns A Guide to HPLC and LC-MS Buffer Selection.
Dong, M.W., Boyes, B.E., 2018. Modern Trends and Best Practices in Mobile-Phase Selection in Reversed-Phase Chromatography. LC-GC Eur. 31, 572–583.
European Medicines Agency, 2011. Guideline on bioanalytical method validation.
Food and Drug Administration, 2014. Methods, Method Verification and Validation - ORA-LAB.5.4.5 | FDA.
Goutal, S., Auvity, S., Legrand, T., Hauquier, F., Cisternino, S., Chapy, H., Saba, W., Tournier, N., 2016. Validation of a simple HPLC-UV method for rifampicin determination in plasma: Application to the study of rifampicin arteriovenous concentration gradient. J. Pharm. Biomed. Anal. 123, 173–178.
Kemenkes RI, 2017. Data dan Informasi; Profil Kesehatan Indonesia 2016. Kemenkes Jakarta.
Khatak, S., Khatak, M., Ali, F., Rathi, A., Singh, R., Singh, G.N., Dureja, H., 2018. Development and Validation of a RP-HPLC Method for Simultaneous Estimation of Antitubercular Drugs in Solid Lipid Nanoparticles. Indian J. Pharm. Sci. 80, 996–1002.
Khuhawar, M.Y., Rind, F.M.A., 2002. Liquid Chromatographic Determination of Isoniazid, Pyrazinamide and Rifampicin From Pharmaceutical Preparations and Blood. J. Chromatogr. B Analyt. Technol. Biomed. Life. Sci. 766, 357–363.
Moosavi, S.M., Ghassabian, S., 2018. Linearity of Calibration Curves for Analytical Methods: A Review of Criteria for Assessment of Method Reliability. Calibration Valid. Anal. Methods - Sampl. Curr. Approaches.
Oliveira, M.A.L., Chellini, P.R., Amorim, T.L., 2018. Simultaneous determination of rifampicin, isoniazid, pyrazinamide and ethambutol in fixed-dose combination antituberculosis pharmaceutical formulations: A review. Anal. Methods 10, 1103–1116.
Schellinger, A.P., Carr, P.W., 2014. Solubility of Buffers in Aqueous–Organic Effluents for Reversed-Phase Liquid Chromatography. LCGC N. Am. 22, 544–548.
Shabir, G.A., Lough, W.J., Arain, S.A., Bradshaw, T.K., 2007. Evaluation and Application of Best Practice in Analytical Method Validation. J. Liq. Chromatogr. Relat. Technol. 30, 311–333.
Shah, U.H., Jasani, A.H., 2014. UV Spectrophotometric and RP- HPLC Methods For Simultaneous Estimation of Isoniazid, Rifampicin and Piperine In Pharmaceutical Dosage Form. Int. J. Pharm. Pharm. Sci. 6, 274–280.
United States Pharmacopeia, 2018. Rifampicin USP 41 The National Formulary 36. U.S. Pharmacopeial Convention, Inc., Rockville.
Vella, J., Mifsud, M., Bartolo, N.S., Ferrito, V., Serracino-Inglott, A., Azzopardi, L.M., Laferla, G., 2014. The Combined Effects of Ph and Acetonitrile Composition on The Separation of Two Lincosamide Antibiotics. Asian J. Pharm. Clin. Res. 7, 96–100.
World Health Organization, 2019. Global Tuberculosis Report 2019. World Health Organization, Geneva.
World Health Organization, 2017. Guidelines for Treatment of Drug-Susceptible Tuberculosis and Patient Care. World Health Organization, Geneya.
Authors
Andi Suhendi and Ayusari Ramly, E. . (2021) “Validasi Metode Analisis Kapsul Rifampisin Dengan HPLC-PDA”, Farmasains : Jurnal Ilmiah Ilmu Kefarmasian, 8(1), pp. 31–36. doi: 10.22236/farmasains.v8i1.5602.
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