DOI QR코드

DOI QR Code

An HPLC method for the determination of thioctic acid in raw material and tablets

  • Mai, Xuan-Lan (College of Pharmacy, Kangwon National University) ;
  • Ahn, GyeChan (College of Pharmacy, Kangwon National University) ;
  • Lee, SeokHan (College of Pharmacy, Kangwon National University) ;
  • Kang, Jong-Seong (College of Pharmacy, Chungnam National University) ;
  • Woo, Mi Hee (College of Pharmacy, Catholic University of Daegu) ;
  • Na, Dong-Hee (College of Pharmacy, Chungang University) ;
  • Chun, In-Koo (The Society of Korean Official Compendium for Public Health) ;
  • Kim, Kyeong Ho (College of Pharmacy, Kangwon National University)
  • Received : 2017.09.26
  • Accepted : 2017.10.13
  • Published : 2017.10.25

Abstract

Thioctic acid is a vitamin-like antioxidant which is prepared as tablets and injection. The Korean Pharmacopoeia (KP XI) contains monograph for the quality control of raw thioctic acid using ultra-violet visible spectrophotometry and its formulations using high performance liquid chromatography (HPLC). In British Pharmacopoeia 2013 (BP2013), another HPLC method is used for the assay test of thioctic acid material. For the international harmonization, we present an HPLC method for quantitation of thioctic acid in both raw material and tablets. Method validation was performed to determine linearity, precision, accuracy, system suitability, and robustness. The linearity of calibration curves in the desired concentration range was high ($r^2=0.9995$), while the RSDs for intra- and inter-day precision were 0.93 ~ 1.26 % and 1.40 ~ 1.76 %, respectively. Accuracies ranged from 98.13-100.00 %. Since the system suitability, intermediate-precision and robustness of the assay were satisfactory, this method will be a valuable addition to the Korean Pharmacopoeia (KP XI).

Keywords

References

  1. Human Metabolome Database, http://www.hmdb.ca/metabolites/HMDB01451.
  2. Ministry of Food and Drug Safety, The Korean Pharmacopoeia, 11th Edition, Republic of Korea (2014).
  3. The United States Pharmacopeial Convention, The United States Pharmacopeia, USP 39 NF 34, United States (2016).
  4. The Ministry of Health, Labour and Welfare, The Japanese Pharmacopoeia, 17th Edition, Japan (2016).
  5. Medicines & Healthcare Products Regulatory Agency, British Pharmacopoeia, 7th Edition, United Kingdom (2013).
  6. ICH Guideline. Q2(R1): validation of Analytical Procedures: Text and Methodology Q2(R1) in ICH Harmonised Tripartite Guideline (2005).
  7. Ministry of Food and Drug Safety No. 2009-173 (2009. 15), Republic of Korea.
  8. Ministry of Food and Drug Safety, No. C0-2012-2-005 (2012. 09. 19), Republic of Korea.