UJI VALIDASI METODE DAN PENETAPAN KADAR RANITIDIN DALAM SEDIAAN TABLET SECARA SPEKTROFOTOMETRI UV
METHOD VALIDATION TEST AND DETERMINATION OF RANITIDINE CONTENT IN TABLET PREPARATIONS BY UV SPECTROPHOTOMETRY
DOI:
https://doi.org/10.37090/jfl.v13i2.1805Abstract
This study aims to determine the levels of ranitidine in generic and trade name tablet preparations by UV spectrophotometry. Based on the results obtained linearity value of r = 0.9999 with limit of detection (LOD) 0.1667 ppm and limit of quantitation (LOQ) 0.5558 ppm. Precision obtained RSD results of 0.641% and in accuracy obtained % recovery at 3 concentrations of 9, 12 and 15 ppm respectively 101.05; 100.63; and 100.33%. The results of the determination of levels in ranitidine tablet preparations with five generic tablets and five trade name tablets have met the requirements for levels in medicinal preparations for ranitidine tablet preparations according to the Indonesian Pharmacopoeia VI Edition, which contains ranitidine not less than 90.0% and not more than 110.0%. It can be concluded that the UV spectrophotometric method used in the study has met the parameters set in the validation test so that this method can be applied to the analysis of determining ranitidine levels in a laboratory.
Keywords: Ranitidine, UV Spectrophotometry, Method validation
References
[1] Sari, I. dan Febrina, E. 2023. Review: Penggunaan Off-Label Obat Golongan Antagonis Reseptor Histamin 2. Journal of Pharmaceutical and Sciences, 6(1): 266–272.
[2] Mahdayana, I. Dayang, Sudjatmiko, Sumarno dan Padolo, E. 2015. Studi Penggunaan Profilaksis Stress Ulcer pada Pasien Bedah Digestif di RSUD dr. Soetomo Surabaya. Pharmaceutical Journal of Indonesia, 5(2) : 73-78.
[3] Chandra, B., Rivai, H. dan Marianis, M. 2016. Pengembangan Dan Validasi Metode Analisis Ranitidin Hidroklorida Tablet Dengan Metode Absorbansi Dan Luas Daerah Di Bawah Kurva Secara Spektrofotometri Ultraviolet. Jurnal Farmasi Higea, 8(2): 96–109.
[4] Paul, S., Barai, L., Husen, F., Sarker, S., Pal, T.K., Bai, P., Matin, S. M. A., Saima, A. S. dan Biswas, S. 2020. Analytical Method Development and Validation for Estimation of Ranitidin in Solid Dosage Form by UV-Spectrophotometric Method. Oriental Journal Of Chemistry, 36(6): 1161–1167.
[5] Amalia, T. 2018. Tanggung Jawab Industri Farmasi Terhadap Penerapan Aturan Pemerintah Tentang Cpob. Jurnal Inkofar, 1(1): 59–67.
[6] Rohman, A. 2016. Validasi dan Penjaminan Mutu Metode Analisis Kimia. Graha Ilmu. Yogyakarta.
[7] Naid, T., Kasim, S. dan Pakaya, M. 2011. Majalah Farmasi dan Farmakologi. Fakultas Farmasi Universitas Hasanuddin. Makassar.
[8] Bajaj, S., Singla, D. dan Sakhuja, N. 2012. Stability testing of pharmaceutical products. Journal of applied pharmaceutical science, 2(3),129-138.
[9] Departemen Kesehatan RI. 2020. Farmakope Indonesia. Edisi VI. Departemen Kesehatan RI. Jakarta.
[10] Harahap, M.R., Ulandari, A.S., Sulistiyana, M.S., Fardani, R.A., dan Suhada, A. 2023. Buku Ajar Kimia Farmasi. UGM Press. Yogyakarta.
[11] Harmono, H. D. 2020. Validasi Metode Analisis Logam Merkuri (Hg) Terlarut pada Air Permukaan dengan Automatic Mercury Analyzer. Indonesian Journal of Laboratory, 2(3): 11.
[12] Riyanto, P.D. 2014. Validasi dan Verifikasi Metode Uji. Deepublish. Yogyakarta.
[13] Gandjar, I.G. dan Rohman, A. 2013. Kimia Farmasi Analisis. Pustaka Pelajar. Yogyakarta.
[14] Harmita. 2004. Petunjuk Pelaksanaan Validasi Metode dan Cara Perhitungannya. Majalah Ilmu Kefarmasian, 117-135.
[15] Mirmehrabi, M., Rohani, S., Murthy, K.S.K. dan Radatus, B. 2004. Solubility, dissolution rate and phase transition studies of ranitidine hydrochloride tautomeric forms. International Journal of Pharmaceutics, 282(1–2): 73–85.