Browse > Article

HPLC Chromatographic Methods for Simultaneous Determination of Pholcodine and Ephedrine HCI with Other Active Ingredients in Antitussive-Antihistamine Oral Liquid Formulations  

Abdallah, Rokia M. (Pharmacognosy Department, Faculty of Pharmacy, University of Alexandria)
Publication Information
Natural Product Sciences / v.12, no.1, 2006 , pp. 55-61 More about this Journal
Abstract
A description of simple, isocratic and precise reversed phase HPLC methods is given for simultaneous quantification of pholcodine and ephedrine hydrochloride together with either carbinoxamine maleate or terfenadine in antitussive-antihistaminic oral pharmaceutical formulations. Separations were carried out on X-Terra and symmetry shield C18 column $(250\;{\times}\;4.6\;mm,\;5\;{\mu}m)$. The used isocratic elution systems were either $0.02\;M\;KH_2PO_4-acetonitrile$ in the ratio of 75 : 25 and pH adjusted to 7.70 with orthophosphoric acid or sodium hydroxide, for syrup (method A), or 0.02 octanesulphonic acid sodium salt solution-acetonitrile-acetic acid in the ratio of 75 : 25 : 0.5 for suspension (method B). The elution of both mixtures was achieved with a flow rate of 1 ml/min. Detection was carried out by UV absorbance at wavelengths of 220 and 250 nm for syrup and suspension, respectively. The quantification of the components in synthetic mixtures and actual syrup and suspension were calculated using the internal standard technique with metoclopramide HCl and codeine phosphate as internal standards (IS), respectively. The methods, for both mixtures, were validated and met all the requirements for the quality control analysis recommended by FDA and ICH.
Keywords
pholcodine; ephedrine HCl; carbinoxamine maleate; terfenadine; HPLC;
Citations & Related Records

Times Cited By SCOPUS : 1
연도 인용수 순위
1 Badwan, A.A., Al-Kaysi, H.N., Owais, L.B., Salem, M.S., and Arafat, T.A., Terfenadine in Analytical Profile of Drug Substances, Florey, K. (Editor), Academic Press, London, pp 627-634 (1990)
2 Cao, H.P., Wang, D.R., and Song, X.J., Assay of compound pholcodine in cough syrup by HPLC. Yaowu Fenxi Zazhi, 19(6), 397-399 (1999)
3 Carnevale, L., Simultaneous determination of acetaminophen, guaifenesin, pseudoephedrine, pholcodine, and paraben preservative in cough mixture by high-performance liquid chromatography. J. Pharm. Sci., 72(2), 196-198 (1983)   DOI
4 Gil-Agusti, M., Monferrer-Pons, L., Garcia-Alvarez-Coque, M., and Esteve-Romero, J., Determination of active ingredients in cough-cold preparations by micellar liquid chromatography. Talanta, 54(4), 621-630 (2001a)   DOI   ScienceOn
5 Gil-Agusti, M., Capella-Perio, M.E., Monferrer-Pons, L., Garcia-Alvarez-Coque, M.C., and Esteve-Romero, J., Chromatographic analysis of phenethylamine-antihistamine combinations using C8, C18 or cyano columns and micellar sodium dodecyl sulphate-pentanol mixtures. Analyst (Cambridge-UK), 126(4), 457-464 (2001c)   DOI   ScienceOn
6 Lau, O.W., Chan, K., Lau, Y.K., and Wong, W.C., The simultaneous determination of active ingredients in cough-cold mixtures by isocratic reversed-phase ion-pair high-performance liquid chromatography. J. Pharm. Biomed. Anal., 7(6), 725-736 (1989)   DOI   ScienceOn
7 Le-Hazif, D., Lefort-des-Ylouses, D., Levillain, P., and Dubois, P., Simultaneous determination of phenylpropanolamine hydrochloride and carbinoxamine maleate by first-derivative ultra-violet spectrophotometry. Analusis, 24(4), 156- 158 (1996)
8 Masuda, M., Satoh, T., Handa, M., Itoh, Y., and Sagara, K., Simultaneous determination of the components in an anti-cold drug by gradient HPLC. Bunseki-Kagaku, 46(10), 777-783 (1997)   DOI   ScienceOn
9 Yu, W.M. and You, S.L., Determination of compound pholcodine oral solution by HPLC and TLC. Zhongguo-Yiyao-GongyeZazhi, 33(3), 134-136 (2002)
10 ICH, Stability testing of new drug substances and products, Proceedings of the International Conference on Harmonization, IFPMA, Geneva, 2003
11 Shoukrallah, I., Determination of phenylephrine hydrochloride and carbinoxamine maleate in capsules and diphenhydramine hydrochloride and naphazoline hydrochloride in nasal jelly by first-order derivative UV spectroscopy. Acta Pharm. Jugosl., 41(2), 107-115 (1991)
12 Findlay, J.W., Pholcodine. J. Clin. Pharm. Ther. 13(1), 5-17 (1988)   DOI
13 Hood, D.J. and Cheung, H.Y. A chromatographic method for rapid and simultaneous analysis of codeine phosphate, ephedrine HCl and chlor-pheniramine maleate in cough-cold syrup formulation. J. Pharm. Biomed Anal., 30(5), 1595-1601 (2003)   DOI   ScienceOn
14 Lau, O.W. and Mok, C.S., High-performance liquid chromatographic determination of active ingredients in cough-cold syrups with indirect conductometric detection. J. Chromatography-A, 693(1), 45-54 (1995)   DOI   ScienceOn
15 Ali, S.L., Ephedrine Hydrochloride in Analytical Profile of Drug Substances, Florey, K. (Editor), Academic Press, London, pp. 233-281 (1986)
16 Mansour, A.M., Determination of pseudoephedrine hydrochloride and carbinoxamine maleate in combination drug formulation by liquid chromatography. J. Assoc. Off. Anal. Chem., 81 (5), 958-962 (1998)
17 British Pharmacopoeia, Her Majesty's Stationary Office, London, 2004
18 Argekar, A.P., Shah, S.J., and Raj, S.V., Simultaneous determination of pseudoephedrine hydrochloride (PSE) and terfenadine (TER) from formulations by reversed-phase ion pair high-performance liquid chromatography (RP-HPLC). Drug Dev. Ind. Pharm., 24(3), 219-223 (1998)   DOI
19 Lau, O.W. and Cheung, Y. Simultaneous determination of some active ingredients in cough-cold syrups by gas-liquid chromatography. Analyst (Cambridge-UK), 115 (10), 1349-1353 (1990)   DOI   ScienceOn
20 The United States Pharmacopoeia 27 Revision, United States Pharmacopeial Convention, Inc., Rockville, MD, USA, 2004
21 Raman, R., Yadgire, S.K., and Raman, B., An improved method for simultaneous determination of pseudoephedrine hydrochloride and terfenadine in tablets by reverse-phase HPLC. Indian Drugs, 38(6), 307-312 (2001)
22 Gennaro, A.R., Chief Editor, Remington Pharmaceutical Sciences, 18th Edition, Mack Publishing Company, Easton, Pennsylvania, 1990
23 Gasco-Lopez, A.I., Izquirerdo-Hornillos, R., and Jiminez, A., Development and validation of a high-performance liquid chromatography method for the determination of cold relief ingredients in chewing gum. J. Chromatogr-A, 775(1-2), 179-185 (1997)   DOI   ScienceOn
24 Gil-Agusti, M., Monferrer-Pons, L., Esteve-Romero, J., and Garcia-Alvarez-Coque, M.C., Quantification of antihistamines in pharmaceutical preparations by liquid chromatography with a micellar mobile phase of sodium dodecyl sulphate and pentanol. J. Assoc. Off. Anal. Chem., 84(6), 1687-1694 (2001b)
25 Parfitt, K. Editor, Martindale: The Complete Drug Reference, 33rd Edition, The Pharmaceutical Press, London, 2002