VALIDASI METODE ANALISIS DAN PENGUJIAN FORCE DEGRADATION STUDY PADA MEREK DAGANG YANG MENGANDUNG PARACETAMOL

  • Chresiani Destianita Yoedistira Program Studi Farmasi, Universitas Ma Chung
  • Gytha Novella Ongkowijoyo Program Studi Farmasi, Universitas Ma Chung
Keywords: Paracetamol, Forced Degradation Study, UV-Vis spectrophotometer

Abstract

Paracetamol is the drug most consumed by the public,so it’s necessary to carry out strict quality assurance. Therefore, a forced degradation study was carried out using a UV-Vis spectrophotometer with various degradation conditions recommended by ICH. The research was conducted on five brands of paracetamol tablets that were treated with hydrolysis, oxidation, photolytic, and thermal treatment, which were detected by UV-Vis spectrophotometer at a wavelength of 243nm. The developed method is validated with linearity, selectivity, accuracy, precision, detection limit, and quantification parameters. The results obtained are selective, linear with a regression of 0.99; accurate with %Recovery between 99.4 - 100.9% and %CV <2%; and precision with %RSD <2%; LOD 24.35706967 mg/L; LOQ 79.95750448 mg/L. The five brands of drugs tested were subjected to hydrolysis, oxidation, photolysis, and thermal degradation. Under alkaline and oxidizing conditions, it was found that the degradation was beyond the limit of levels, according to the Indonesian Pharmacopoeia 90% - 110%.

References

Bertolini, A. et al., 2006, ‘Paracetamol: New Vistas of an Old Drug’, CNS Drug Reviews, 12, 250–275.

DepKes, 2020, Farmakope Indonesia Edisi VI, Departemen Kesehatan Republik Indonesia. Jakarta.

Harmita, 2004, ‘Petunjuk Pelaksanaan Validasi Metode dan Cara Perhitungannya’, Majalah Ilmu Kefarmasian, 1, 117–135.

Naveed, S., Waheed, N. and Nazeer, S., 2014, ‘Degradation Study f Metronidazole in Active and Different Formulation by UV Spectroscopy’, Journal of Bioequivalece & Bioavailability, 6, 124–127.

Venkataraman, S. and Manasa, M., 2018, ‘Forced degradation studies: Regulatory guidance, characterization of drugs, and their degradation products - a review’, Drug Invention Today.

Published
2022-03-29
How to Cite
Yoedistira, C., & Ongkowijoyo, G. (2022). VALIDASI METODE ANALISIS DAN PENGUJIAN FORCE DEGRADATION STUDY PADA MEREK DAGANG YANG MENGANDUNG PARACETAMOL. Jurnal Ilmiah Ibnu Sina, 7(1), 92-101. https://doi.org/10.36387/jiis.v7i1.829
Section
Artikel