• Analytical Science and Technology
• /
• v.30 no.5
• /
• pp.221-225
• /
• 2017

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).

• Journal of Pharmaceutical Investigation
• /
• v.36 no.6
• /
• pp.413-419
• /
• 2006

In this study, the main purpose was to evaluate the bioequivalence of two thioctic acid tablests, Thioctacid HR tablet(Bukwang Pharm. Co., Ltd.) and Daewon thioctic acid HR tablet 600 mg(Daewon Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration(KFDA). Twenty-four, healthy Korean volunteers were divided into two groups, randomized and treated by $2{\times}2$ crossover study. After the administration of one thioctic acid tablet containing 600 mg thioctic acid, blood samples were taken until 8 hr after the oral administration. LC-MS/MS was applied to determination of thioctic acid, and we calculated the $AUC_t,\;C_{max},\;T_{max}$ from the plasma concentration-time data. Analysis of variance(ANOVA) was carried out using logarithmically transformed $AUC_t\;and\;C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for Daewon thioctic acid tablet 600 mg/Thioctacid HR were log 0.9877$\sim$log 1.1938 and log 0.8169$\sim$log 1.2237, respectively. These values were within the acceptable bioequivalence intervals of log 0.80$\sim$log 1.25, recommended by KFDA. In all of these results we concluded that Daewon thioctic acid tablet 600 mg was bioequivalent to Thioctacid HR tablet, in terms of rate and extent of absorption.

• Bulletin of the Korean Chemical Society
• /
• v.25 no.4
• /
• pp.517-524
• /
• 2004

Two simple and sensitive spectrophotometric methods were developed for the determination of carbocisteine, penicillamine, ethionamide and thioctic acid in bulk and in their pharmaceutical preparations using alkaline potassium permanganate as an oxidizing agent. The first one involves determination of ethionamide and thioctic acid by spectrophotometric investigation of the oxidation reaction of the two drugs. The second method involves determination of carbocisteine and penicillamine by kinetic studies of the oxidation reaction of these two drugs at room temperature for a fixed time of 20 minutes. The absorbance of the colored manganate ions was measured at 610 nm in both methods. 1-10 ${\mu}$g/mL of ethionamide and thioctic acid could be etermined by the spectrophotometric method with detection limits of 0.11 and 0.089 ${\mu}$g/mL for the two drugs respectively. 2-10 ${\mu}$g/mL of carbocisteine and penicillamine could be determined by the kinetic method with detection limits of 0.14 and 0.21 ${\mu}$g/mL respectively. The two methods were successfully applied for the determination of these drugs in their dosage forms.

• Journal of Korean Foot and Ankle Society
• /
• v.26 no.4
• /
• pp.177-182
• /
• 2022

Purpose: The efficacy and safety of low-dose pregabalin and alpha lipoic acid in diabetic neuropathy were evaluated and analyzed. Materials and Methods: This study designed a retrospective study that included patients with diabetic neuropathic pain. From 2009 to 2022, 100 patients who suffered from diabetic neuropathic pain were included in this study. The patients were divided into group I (pregabalin 150 mg/day with alpha lipoic acid 600 mg/day) and group II (pregabalin 300 mg/day with alpha lipoic acid 600 mg/day). The visual analogue scale (VAS), medication side effects, and neurometer results were compared. Results: The mean follow-up period of the above patients was 120.23 weeks in group I and 149.05 weeks in group II. The average VAS score in group I decreased by 3.23 points, and the average VAS score in group II decreased by 2.86 points. Approximately 24.3% of group I had side effects, such as dizziness, sleepiness, and gastrointestinal trouble, while 76.7% of patients in group II had side effects. Sixtyseven patients had a neurometer examination before and after the medication, and there is no statistical difference between the two groups. Conclusion: The combination of low-dose pregabalin (pregabalin 150 mg/day) and alpha lipoic acid in diabetic neuropathy had a similar clinical effect and less frequent medication side effects than regular dose pregabalin (pregabalin 300 mg/day) and alpha lipoic acid. Therefore, low-dose pregabalin (pregabalin 150 mg/day) and alpha lipoic acid should be considered in treating diabetic neuropathy.