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Development of Analytical Method for Ambroxol Hydrochloride and Clenbuterol Hydrochloride Formulation in Korean Pharmaceutical Codex  

Lee, Tae-Woong (Hazardous Substances Analysis Division, Daejeon regional Korea Food & Drug Administration)
Jeong, Rae-Seok (Hazardous Substances Analysis Division, Daejeon regional Korea Food & Drug Administration)
Park, Soo-Jin (Hazardous Substances Analysis Division, Daejeon regional Korea Food & Drug Administration)
Choi, Lan (National Institute of Food and Drug Safety Evaluation, Osong Health Technology Administration Complex)
Shim, Young-Hun (National Institute of Food and Drug Safety Evaluation, Osong Health Technology Administration Complex)
Choi, Bo-Kyung (National Institute of Food and Drug Safety Evaluation, Osong Health Technology Administration Complex)
Kwak, Hyo-Sun (Hazardous Substances Analysis Division, Daejeon regional Korea Food & Drug Administration)
Publication Information
YAKHAK HOEJI / v.58, no.3, 2014 , pp. 190-199 More about this Journal
Abstract
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.
Keywords
method validation; ambroxol hydrochloride; clenbuterol hydrochloride;
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1 Hadad, G. M., El-Gindy, A. and Mahmoud, W. M. M. : HPLC and chemometrics-assisted UV-spectroscopy methods for the simultaneous determination of ambroxol and doxycycline in capsule. Spectrochim. Acta, Part A 70, 655 (2008).   DOI   ScienceOn
2 Dharuman, J., Vasudhevan, M. and Ajithlal, T. : High performance liquid chromatographic method for the determination of cetirizine and ambroxol in human plasma and urine-A boxcar approach. J. Chromatogr. B 879, 2624 (2011).   DOI   ScienceOn
3 Shaikh, K. A., Patil, S. D. and Devkhile, A. B. : Development and validation of a reversed-phase HPLC method for simultaneous estimation of ambroxol hydrochloride and azithromycin in tablet dosage form. J. Pharm. Biomed. Anal. 48, 1481 (2008).   DOI   ScienceOn
4 Rote, A. R. and Kande, S. K. : Development of HPTLC method for determination of cefpodoxime proxetil and ambroxol hydrochloride in human plasma by liquid-liquid extraction. Pharm. Methods 2, 242 (2011).   DOI
5 Bazylak, G. and Nagels, L. J. : Simultaneous high-throughput determination of clenbuterol, ambroxol and bromhexine in pharmaceutical formulations by HPLC with potentiometric detection. J. Pharm. Biomed. Anal. 32, 887 (2003).   DOI
6 Abdel-Ghani, N. T. and Hussein, S. H. : Determination of ambroxol hydrochloride in pure solutions and some of its pharmaceutical preparations under batch and FIA conditions. Il Farmaco 58, 581 (2003).   DOI   ScienceOn
7 Trejo, F. M., Leon, S. V., Medina, A. E. and Tolentino, R. G. : Application of high-performance liquid chromatography-UV detection to quantification of clenbuterol in bovine liver samples. JFDA 21, 414 (2013).
8 Furusawa, N. : An isocratic solvent-free mobile phase HPLC-PDA analysis of clenbuterol and ractopamine. Int. J. Chem. Anal. Sci. 4, 169 (2013).   DOI
9 Liu, B., Yan, H., Qiao, F. and Geng, Y. : Determination of clenbuterol in porcine tissues using solid-phase extraction combined with ultrasound-assisted dispersive liquid-liquid microextraction and HPLC-UV detection. J. Chromatogr. B 879, 90 (2011).   DOI   ScienceOn
10 식품의약품안전처 고시 : 의약품동등성시험기준 (2013).
11 대한민국약전 10개정 : 일반시험법 (2013).
12 Hasegawa, I., Niisato, N., Iwasaki, Y. and Marunaka, Y. : Ambroxol-induced modification of ion transport in human airway Calu-3 epithelia. Biochem. Biophys. Res. Commun. 343, 475 (2006).   DOI   ScienceOn
13 Martin, P., Soubrie, P. and Simon, P. : Does a single priming injection of clenbuterol alter behavioral response to ${\beta}$-adrenoceptor agonists and antagonists in mice through a timedependent process. Eur. J. Pharmacol. 115, 91 (1985).   DOI   ScienceOn
14 Yamada, T., Takemura, Y., Niisato, N., Mitsuyama, E., Iwasaki, Y. and Marunaka, Y. : Action of N-acylated ambroxol derivatives on secretion of chloride ions in human airway epithelia. Biochem. Biophys. Res. Commun. 380, 586 (2009).   DOI   ScienceOn
15 Lee, H. J., Joung, S. K., Kim, Y. G., Yoo, J.-Y. and Han, S. B. : Bioequivalence assessment of ambroxol tablet after a single oral dose administration to healthy male volunteers. Pharmacol. Res. 49, 93 (2004).   DOI   ScienceOn
16 Cho, Y., Jang, Y. Y., Han, E. S. and Lee, C. S. : The inhibitory effect of ambroxol on hypochlorous acid-induced tissue damage and respiratory burst of phagocytic cells. Eur. J. Pharmacol. 383, 83 (1999).   DOI   ScienceOn
17 Kazanietz, M. G., Gutkind, J. S. and Enero, M. A. : Interaction between ${\beta}2$- and ${\alpha}2$-adrenoceptor responses in the vascular system: effect of clenbuterol. Eur. J. Pharmacol. 130, 119 (1986).   DOI
18 Re, G., Badino, P., Girardi, C. and Carlo, F. D. : Effects of a ${\beta}2$-agonist (clenbuterol) on cultured human (CG-5) breast cancer cells. Pharmacol. Res. 26, 377 (1992).   DOI   ScienceOn
19 Yamashita, J., Nagase, H., York, D. A. and Bray, G. A. : Effects of clenbuterol, a ${\beta}2$-Adrenoceptor agonist, on Macronutrient selection in rats. Physiology & Behavior 56, 251 (1994).   DOI
20 Fabre, J., Bousquet, J., Lebel, B., Jirou-Najou, J. L., Cluzel, M., Godard, P. and Michel, F. B. : Anti-allergic activity of an oral beta-2 agonist, clenbuterol. J. Allergy Clin. Immunol. 81, 311 (1988).
21 식품의약품안전처 : 2013 식품의약품통계연보 (2013).
22 식품의약품안전처 고시 : 대한민국약전외 의약품 기준 (2013).
23 대한민국약전 10개정 : 의약품등 시험방법 밸리데이션 가이드라인 (2013).
24 Elfinger, M., Geiger, J., Hasenpusch, G., Uzgun, S., Sieverling, N., Aneja, M. K., Maucksch, C. and Rudolph, C. : Targeting of the $\beta2$-adrenoceptor increases nonviral gene delivery to pulmonary epithelial cells in vitro and lungs in vivo. J. Controlled Release 135, 234 (2009).   DOI   ScienceOn
25 ICH : Validation of Analytical Procedures : Text and Methodology Q2(R1) (2005).
26 Society of Japanese Pharmacopoeia : The Japanese Pharmacopoeia 16th (2011).
27 식품의약품안전청 : 대한민국약전 개정안 작성지침 (2013).
28 FDA, Center for Drug Evaluations and Research, Guidance for Industry-Extended release oral dosage forms : Development, evaluations and application of in vitro/in vivo correlation (1997).
29 United States Pharmacopoeial Convention, Inc. : The United States Pharmacopeia 35th (2009).