Partial Validation of High Performance Liquid Chromatography for Analysis of Isoniazid in Rat Plasma

  • Novi Yantih UNIVERSITAS PANCASILA
  • Siti Hafilah UNIVERSITAS PANCASILA
  • Yahdiana Harahap UNIVERSITAS INDONESIA
  • WAHONO SUMARYONO UNIVERSITAS PANCASILA
  • Rianto Setiabudy UNIVERSITAS INDONESIA

Abstract

Tuberculosis is an infectious disease caused by Mycobacterium tuberculosis. Nicotinic acid derivatives such as isoniazid have the strongest anti-tuberculosis properties. For pharmacokinetics studying of isoniazid (INH), a method is needed to determine the levels of INH in plasma. Objective: The aim of this research is to partial validate of high performance liquid chromatography (HPLC) for analysis of INH in rat plasma. Method: For the preliminary study, rat plasma was used. The HPLC system used is a stationary phase C18 with length 250mm and temperature of 30°C, mobile phase hexane sulphonate acid 20mM pH 2.47–methanol (65:35). The analytical parameters in partial validated were linearity, lower limit of quantification (LLOQ), precision, accuracy, and recovery. Results: The results of linearity test of INH showed r value of 0.9996. LLOQ of this method was 0.1258μg/mL. The resulting accuracy and precision value met FDA requirements with a percent recovery ranging from 96.57–107.99%. Conclusion: The HPLC system was a valid method for analysis of INH in rat plasma.

References

1. Bhandari R, Kaur IP. A sensitive HPLC method for determination of isoniazid in rat plasma, brain, liver, and kidney, J Chromat Separation Techniq, 2012; 3(3). ISSN2157-7064 JCGST.

2. EMEA (European Medicines Agency). 2012. Guideline on bio analytical method validation. EMEA/CHMP/EWP/192217/2009.

3. FDA (Food Drug Administration). 2013. Guidance for industry bio analytical method of validation; available from: www.fda.gov/cder/guidance/index.htm.

4. Madhavi R, Mohana KA, Shobha RG, Mounika D. Isoniazid: A Review of Analytical Methods. Asian J. Pharm. Ana., 2015; 5(1): 41-5.

5. Klein DJ, Boukouvala S, McDonagh EM, Shuldiner SR, Laurieri N, Thorn CF, Altman RB, Klein TE. PharmGKB summary: isoniazid pathway, pharmacokinetics. Pharmacogenet Genomics. 2016 September, 2016; 26(9): 436–444.

6. Peloquin, C. Therapeutic drug monitoring: principles and applications in mycobacterial infections. Drug Ther, 1992; 22:31–36.

7. Segovia RM, Flores GP, Tirado JDT, Romirez XH, Perez MV, Moreno SR. Simultaneous HPLC determination of isoniazid and acetylisoniazid in plasma. Acta chromatograph, 2007; 19:110-18.

8. Stella. 2011. Optimation and validation of analytical method of isoniazid and pyrazinamide in 4 fixed dosecombination (4FDC) Tablet and plasma in vitro by hidh performance liquid chromatography, FMIPA UI. Depok. Indonesia.

9. Thee S, Seddon JA, Donald PR, Seifart HI, Werely CJ, Hesseling AC, Rosenkranz B, Roll S, Magdorf K, Schaaf HS. 2011. Pharmacokinetics of isoniazid, rifampin, and pyrazinamide in children younger than two years of age with tuberculosis: evidence for implementation of revised world health organization recommendations. Antimic Agent and Chemotheraph. Dec 2011. American Society for Microbiology. 5560–7.

10. Unsalam S, Sancar M, Clark M, Karagoz T, Izzettin FV, Rollas S. Therapeutic monitoring of isoniazid, pyrazinamide, and rifampisin in tuberculosis patients using LC. J Chromatogr., 2005; No 61.

11. WHO (World Health Organization). 2011. Child growth standards. WHO, Geneva, Switzerland. http: //www.who.int/childgrowth/standards/weight_for_age/en/index.html.
Published
2018-04-27
How to Cite
YANTIH, Novi et al. Partial Validation of High Performance Liquid Chromatography for Analysis of Isoniazid in Rat Plasma. JURNAL ILMU KEFARMASIAN INDONESIA, [S.l.], v. 16, n. 1, p. 67-71, apr. 2018. ISSN 2614-6495. Available at: <http://jifi.farmasi.univpancasila.ac.id/index.php/jifi/article/view/497>. Date accessed: 27 apr. 2024. doi: https://doi.org/10.35814/jifi.v16i1.497.
Section
Articles