An HPLC method for the determination of thioctic acid in raw material and tablets
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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 (r2 = 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).
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 (r2 = 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).
참고문헌 (8)
- "Human Metabolome Database"[URL]
- Ministry of Food and Drug Safety, "The Korean Pharmacopoeia", ~ (2014)
- The United States Pharmacopeial Convention, "The United States Pharmacopeia, USP 39 NF 34", ~ (2016)
- The Ministry of Health, Labour and Welfare, "The Japanese Pharmacopoeia", ~ (2016)
- Medicines & Healthcare Products Regulatory Agency, "British Pharmacopoeia", ~ (2013)
- "ICH Guideline. Q2(R1): validation of Analytical Procedures: Text and Methodology Q2(R1) in ICH Harmonised Tripartite Guideline", ~ (2005)
- "Ministry of Food and Drug Safety No. 2009-173", ~ (2009)
- "Ministry of Food and Drug Safety, No. C0-2012-2-005", ~ (2012)