• 약학회지
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• 제58권3호
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• pp.190-199
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• 2014

The Korean Pharmaceutical Codex (KPC) analytical method of ambroxol hydrochloride and clenbuterol hydrochloride formulation is complicated and needed to carry out multiple processes during the test. To improve the low efficiency of analytical procedure that makes pharmaceutical laboratory consume much time and high cost to conduct the test of this formulation, this study was performed for simplifying the pretreatment process and optimizing conditions of the HPLC assay. The analytical procedure using HPLC was developed to establish analytical specification for ambroxol hydrochloride and clenbuterol hydrochloride formulations. The newly developed analytical method has good linearity ($R^2$ >0.999), specificity, precision (RSD<1.0%) and the recovery ranges of 98.50~101.84% for ambroxol, 98.29~101.35% for clenbuterol syrup and 98.66~101.71% for clenbuterol tablets. The LOQs were 0.204 ${\mu}g/ml$ for ambroxol, 0.021 ${\mu}g/ml$ for clenbuterol syrup and 0.073 ${\mu}g/ml$ for clenbuterol tablets. The new method was performed with commercially available samples to confirm analytical conditions and validated to be suitable for saving time and cost to control the quality of routine manufactured products. This analytical method will be used for revising the monograph of ambroxol hydrochloride and clenbuterol hydrochloride formulation in next supplement of KPC.

• 대한화학회지
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• 제52권6호
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• pp.622-629
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• 2008

• Journal of Pharmaceutical Investigation
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• 제33권3호
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• pp.215-221
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• 2003

A bioequivalence study of $Ambrect^{TM}$ tablets (Dong Wha Pharm. Ind. Co., Ltd.) to $Mucopect^{TM}$ tablets (Boehringer Ingelheim Korea, Ltd.) was conducted according to the guideline of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korea volunteers received each medicine at the ambroxol hydrochloride dose of 30 mg in a $2{\times}2$ crossover study. There was a one-week wash out period between the doses. Plasma concentrations of ambroxol were monitored by a high-performance liquid chromatography for over a period of 24 hours after the administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 24 hr) was calulated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}\;(time\;to\;reach\;C_{max})$ were compiled from the plasma concentration-time data. Analysis of variance 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 $Ambrect^{TM}/Mucopect^{TM}$ were 0.89-1.01 and 0.89-1.02, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the bioequivalence of $Ambrect^{TM}\;and\;Mucopect^{TM}$ with respect to the rate and extent of absorption.

• 한국임상약학회지
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• 제16권1호
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• pp.28-33
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• 2006

The stability of cefditoren in three kinds of oral liquid preparations at 4 and $25^{\circ}C$ was studied for 90 days. Two tablets of 100 mg cefditoren pivoxil were mixed with 200 mL of each oral liquid syrup, which is Pebron syrup (oxolamine citrate 10 mg/mL), $Mucopect^{(R)}$ syrup (ambroxol hydrochloride 3 mg/mL) or $Tyrenol^{(R)}$ suspension (acetaminophen encapsulated 32 mg/mL). Three samples of each formulation were refrigerated $(4^{\circ}C)$ and three were stored at room temperature $(25^{\circ}C)$. At predetermined time, samples were assayed by stability-indicating HPLC method. The chromatographic analysis after deliberate degradation showed no evidence of any breakdown product likely to interfere with the chromatographic peak of the parent substance. The relation between cefditoren pivoxil concentration and peak area was linear from 10 to $150{\mu}g/mL\;(r^2=0.9998)$. The analysis method was precise, with coefficients of variation no greater than 3.6%. Cefditoren was stable in $Mucopect^{(R)}$ syrup up to 4 weeks regardless of the temperature; in $Tyrenol^{(R)}$ suspension and Pebron syrup, it was stable for at least 28 and 45 days, and 7 and 45 days at 25 and $4^{\circ}C$, respectively. The percentages of initial cefditoren concentration remaining after 90 days were $51.5{\pm}1.8\;and\;80.9{\pm}5.6%,\;61.7{\pm}7.8\;and\;70.2{\pm}7.3%,\;and\;39.9{\pm}3.2\;and\;81.4{\pm}5.5%$ in $Mucopect^{(R)}$ syrup, $Tyrenol^{(R)}$ suspension and $Pebron^{(R)}$ syrup at 25 and $4^{\circ}C$, respectively. The pH variations of all test solutions were minimal, which was within 0.5. The results indicated that the stability of cefditoren was significantly affected by liquid solutions mixed with cefditoren, and storage tempertature.