Analisis Aspirin Menggunakan HPLC Dan Pengujian Validasi Metode
Abstract
Analisis senyawa farmasi, terutama aspirin, membutuhkan metode analisis yang valid dan dapat diandalkan untuk memastikan kualitas dan keamanannya. Metode High-Performance Liquid Chromatography (HPLC) telah menjadi pilihan umum dalam analisis farmasi karena kemampuannya dalam pemisahan senyawa-senyawa kompleks. Penelitian ini memfokuskan pada analisis aspirin menggunakan HPLC dan validasi metodenya, yang menjadi perhatian beberapa peneliti seperti Goussudin dkk (2016), Siswanto dkk (2016), Sultan dkk (2014), dan penelitian lainnya. Goussudin dkk (2016) menghasilkan validasi metode HPLC yang unggul untuk aspirin dan clopidogrel, mengacu pada panduan ICH. Rentang linearitas yang luas menunjukkan keunggulan metode ini, dengan koefisien korelasi mendekati satu, menunjukkan respons linier terhadap konsentrasi. Siswanto dkk (2016) menunjukkan kesesuaian metode HPLC untuk analisis aspirin dan asam salisilat dalam plasma dengan CV di bawah 5%, mendukung aplikasi dalam bioanalisis. Sultan dkk (2014) mengembangkan metode HPLC untuk analisis simultan aspirin, amlodipine, dan simvastatin dalam formulasi, yang tidak hanya sederhana tetapi juga sensitif dan spesifik. Penelitian ini menyoroti pentingnya validasi metode HPLC, mencerminkan dedikasi peneliti untuk menyajikan data yang dapat diandalkan. Berbagai penelitian menunjukkan keberhasilan HPLC dalam analisis simultan senyawa-senyawa farmasi, termasuk aspirin, clopidogrel, amlodipine, simvastatin, omeprazole, warfarin, pravastatin, dan paracetamol. Hasil penelitian ini menegaskan bahwa HPLC adalah alat analisis yang andal dan efektif, teruji, divalidasi, dan diterapkan dengan sukses, memberikan hasil konsisten, akurat, dan presisi dalam berbagai tingkat konsentrasi. Kontribusi metode HPLC ini membantu pengembangan dan pemantauan formulasi farmasi yang melibatkan aspirin dan senyawa terkait, menegaskan perannya dalam konteks analisis farmasi.
References
Dos, B. (2016). Stability indicating RP-HPLC method for simultaneous determination of aspirin and clopidogrel in dosage form. Malaysian Journal of Analytical Sciences, 20(2), 247-257.
Siswanto, A., Fudholi, A., Nugroho, A. K., & Martono, S. (2016). Validasi Metode HPLC untuk Penetapan Aspirin dan Asam Salisilat dalam Plasma Kelinci (Lepus curpaeums) secara Simultan. Jurnal Kefarmasian Indonesia, 66-78.
Sultan, F., Shoaib, M. H., Yousuf, R. I., Ahmed, F. R., Salam, F. A., Nasiri, M. I., ... & Manzoor, S. (2014). Simultaneous quantitation of aspirin, amlodipine and simvastatin in a fixed dose combination of encapsulated tablet formulation by HPLC-UV method. Pakistan Journal of Pharmaceutical Sciences, 27.
Siswanto, A., FUDHOLI, A., NUGROHO, A. K., & MARTONO, S. (2017). Pemodelan Farmakokinetika Tablet Floating Aspirin pada Kelinci dengan PKSolver. JURNAL ILMU KEFARMASIAN INDONESIA, 14(2), 166-173.
Kuncoro, B. (2017). Uji Kesesuaian Sistem Kromatografi Cair Kinerja Tinggi Fase Terbalik pada Bahan Baku Parasetamol. Jurnal Farmagazine, 1(2), 35-41.
Nafisa, S., Rohmah, S., Nihan, Y. A., Nurfadhila, L., & Utami, M. R. (2023). Analisis Senyawa Obat Warfarin dalam Plasma Darah dengan Metode HPLC/KCKT. Journal of Pharmaceutical and Sciences, 6(2), 479-494.
Athota, R. V., Jagarlapudi, S. K., & Singampalli, M. R. (2017). Stability indicating HPLC method for the simultaneous quantification of aspirin and pravastatin in bulk and tablets: method development and validation. Journal of Applied Pharmaceutical Science, 7(3), 048-056.
Jagnade, S., Soni, P., & Omray, L. K. (2020). Development and Validation of a Green Analytical Method for the Determination of Aspirin and Domperidone Bulk or Formulation Using UV and HPLC. Journal of Drug Delivery and Therapeutics, 10(6), 49-56.
Vani, R., & Sunitha, M. (2017). Analytical method development and validation for the determination of omeprazole and aspirin using reverse phase HPLC method in bulk and dosage form. Univers J Pharm Res, 2(4), 25-29.
Siswanto, A., Fudholi, A., Nugroho, A. K., & Martono, S. (2017). Uji Bioavailabilitas Tablet Floating Aspirin. Jurnal Kefarmasian Indonesia, 112-119.
Doshi, J. A., Patel, B. A., & Parmar, S. J. (2013). Development and validation of hplc method for simultaneous determination of aspirin and esomeprazole magnesium in binary mixture. International Journal of Pharmacy and Pharmaceutical Sciences, 5(3), 256-261.
Kamal, A. H., Marie, A. A., & Hammad, S. F. (2020). Stability indicating RP-HPLC method for simultaneous determination of omeprazole and aspirin in the presence of salicylic acid as degradation product. Microchemical Journal, 152, 104350.
Nassar, M. W., Attia, K. A., Mohamed, A. A., & Shahin, M. (2017). HPLC method for the simultaneous estimation of aspirin and omeprazole in their new combination. Analytical Chemistry Letters, 7(3), 438-444.
El-Yazbi, F. A., Amin, O. A., El-Kimary, E. I., Khamis, E. F., & Younis, S. E. (2019). Simultaneous determination of methocarbamol and aspirin in presence of their pharmacopeial-related substances in combined tablets using novel HPLC-DAD method. Drug Development and Industrial Pharmacy, 45(2), 265-272.
Sundar, R. S., & Valliappan, K. (2014). An improved RP-HPLC method for the simultaneous estimation of aspirin, Atorvastatin, And clopidogrel in pharmaceutical formulation using experimental design methodology. Int. J. Pharm. Pharm. Sci, 6, 279-83.
Patel, D., Patel, N., Vaishy, R., Patel, V., Solanki, C., & Patel, M. (2013). Development and validation of RP-HPLC method for simultaneous estimation of aspirin and esomeprazole magnesium in tablet dosage form. Journal of Chemistry, 2013.
El-Ragehy, N. A., Hassan, N. Y., Tantawy, M. A., & Abdelkawy, M. (2016). Simultaneous determination of aspirin, dipyridamole and two of their related impurities in capsules by validated TLC-densitometric and HPLC methods. Journal of chromatographic science, 54(7), 1120-1128.
Kapuganti, A. N. K., Gandhi, B. M., Raju, V. B., Sumanth, K. S., Kagitapurapu, V. K., Srinivas, K., & Harika, P. (2016). Development and Validation of Stability Indicating RP-HPLC Method for Simultaneous Estimation of Ramipril, Aspirin and Simvastatin in Bulk and Pharmaceutical Dosage Form. Asian J. Biomed and pharm sci, 6(53), 14-20.
Sagar, P. V., Samidha, T., Krishna, M. V., & Rani, S. S. (2014). A validated RP-HPLC method for simultaneous estimation of aspirin and prasugrel in tablet dosage form. International Journal of Pharmaceutical Sciences and Research, 5(11), 4858.
Hanwar, D., Utami, W., & Mutiara, P. (2017). Pengembangan dan Validasi Metode Penetapan Kadar Asetosal dan Dipiridamol Secara Simultan dengan Spektrofotometri UV. URECOL, 451-456.
Sarode, T. K., & Jadhav, P. B. (2018). RP-HPLC method development and validation for simultaneous estimation of aspirin and omeprazole in bulk and dosage form. Journal of Drug Delivery and Therapeutics, 8(5), 322-328.
Elkady, E. F., Tammam, M. H., & El Maaty, A. A. (2017). A comparative study of HPLC-UV and UPLC-DAD methods for simultaneous estimation of aspirin and cilostazol in the presence of their related impurities in bulk and capsules. Journal of Liquid Chromatography & Related Technologies, 40(4), 190-198.
Chandarana, C., & Kapupara, P. (2017). Quantitative Simultaneous Estimation of Aspirin and Omeprazole by RP-HPLC method implementing AQbD Approach In Pharmaceutical Dosage Form. risk management, 6, 10.
Rao, N. M., & Gowrisankar, D. (2016). Stability-indicating HPLC Method for Simultaneous Determination of Atenolol, Aspirin, Lisinopril and Simvastatin in Bulk and Tablets. Indian Journal of Pharmaceutical Sciences, 78(2), 217-23.
Attimarad, M., Alkadham, A., Almosawi, M. H., & Venugopala, K. N. (2018). Development of rapid and validated RP-HPLC method for concurrent quantification of rosuvastatin and aspirin form solid dosage form. Indian J. Pharm. Educ. Res, 52(1), 151-158.
Gandla, K., Lalitha, R., Kishore, K., & Gopikrishna, R. (2015). A validated RP-HPLC method for simultaneous estimation of aspirin and rosuvastatin in tablet dosage form. Int. J. Pharm. And chem. res, 1(3), 128-133.
Kamal, A. H., Marie, A. A., & Hammad, S. F. (2020). Stability indicating RP-HPLC method for simultaneous determination of omeprazole and aspirin in the presence of salicylic acid as degradation product. Microchemical Journal, 152, 104350.
Shen, C. L., Huang, X. H., Huang, J. H., Xie, X. F., Zhang, P., Li, L., ... & Tang, H. Q. (2013). Development and validation of a RP-HPLC method for simultaneous determination of warfarin enantiomers, aspirin and salicylic acid in beagle plasma: Application to pharmacokinetic study. Latin American Journal of Pharmacy, 32, 679-687.
Yenduri, G., & Navuluri, S. (2018). Analytical high performance liquid chromatography method for estimating the combination of aspirin and omeprazole in bulk and tablet dosage form. Marmara Pharm J, 22(4), 502-510.
Chaudhari, S. M., Karan, M. P., Luhar, S. V., & Narkhede, S. B. (2018). Rp-hplc method development and validation for simultaneous Estimation of atorvastatin, aspirin, ramipril and metoprolol succinate in tablet dosage form. Pharma science monitor an international journal of pharmaceutical science, 9(2), 205-217.
© 2019 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
