Login Register Cart 0
Generic placeholder image

Current Pharmaceutical Analysis

Editor-in-Chief

ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

Back
Journal Home About Journal Editorial Board Journal Insight Current Issue Volumes/Issues
Subscribe
General Research Article

A Gas Chromatography Flame Ionization Detector Method for Rapid Simultaneous Separation and Determination of Six Active Ingredients of Anticold Drug

Author(s): Fatang Yang, Xiaoyun Duan, Zhen Wang and Yuming Dong*

Volume 18, Issue 1, 2022

Published on: 05 January, 2021

Page: [71 - 81] Pages: 11

DOI: 10.2174/1573412917666210106115211

Abstract

Aims: To establish a rapid and simultaneous determination of multiple effective ingredients in anti-cold drugs.

Background: Anti-cold drugs are stock medicines at home, and most anti-cold formulations are compound preparations. Although the active ingredients of compound preparations have significant effects on the treatment of colds, the excessive dosage or long-term use can produce a series of adverse reactions, including dependence, liver and kidney function damage, digestive system reaction, blood system damage. Now, there are many mature methods for analyzing the active ingredients of anti-cold drugs. However, these methods may have shortcomings, such as a long analysis time or a small number of analysis components.

Objective: Establish a gas chromatography-flame ionization detector method for the simultaneous determination of six active ingredients, including acetaminophen, dextromethorphan hydrobromide, pseudoephedrine hydrochloride, chlorpheniramine maleate, diphenhydramine hydrochloride, and caffeine in anti-cold drugs.

Methods: After the standard was accurately weighed, dissolved in ethanol, filtered by 0.22 μm membrane and ultrasonically degassed, the gas chromatograph was used for detection. After the actual sample was removed from the coating, ground and crushed, accurately weighed, dissolved in ethanol, filtered by 0.22 μm membrane and ultrasonically degassed, the gas chromatograph was used for detection.

Results: The six components can be completely separated within 7.0min. This method has good sensitivity, precision, accuracy and recovery rate. Under the optimum testing conditions, the limit of detection was 0.360-2.50μg/mL, the limit of quantification was 1.20-8.30μg/mL. The calibration curves showed good linearity (R2≥0.9932) over the investigated concentration range between 1.20 and 400μg/mL. The recoveries were 89.2% to 109.2%. The RSD of intra-day precision was less than 1.0%. The RSD of inter-day precision was less than 3.2%. The established method was used to determine the ingredients of three anti-cold drugs on the market, and the results showed that the method can accurately determine the ingredients.

Conclusion: The method can quickly and simultaneously determine multiple active ingredients in anti-cold medicines. Compared with the published methods in literature, the proposed method has the advantages of fast, the number of analysis components wide application range, convenience, low cost, etc. It provides a reference method for quality control of active ingredients of anti-cold drugs.

Keywords: Gas chromatography, flame ionization detector, active ingredients, anti-cold drug, sensitivity, precision.

« Previous Next »
Graphical Abstract

[1]
Chen, H.; Ma, Y.R. The component analysis and reasonable selection of the common anti-cold drugs. J. Pediatr. Pharm, 2004, 10(1), 57-59.
[2]
McCrae, J.C.; Morrison, E.E.; MacIntyre, I.M.; Dear, J.W.; Webb, D.J. Long-term adverse effects of paracetamol - a review. Br. J. Clin. Pharmacol., 2018, 84(10), 2218-2230.
[http://dx.doi.org/10.1111/bcp.13656] [PMID: 29863746]
[3]
Wikoff, D.; Welsh, B.T.; Henderson, R.; Brorby, G.P.; Britt, J.; Myers, E.; Goldberger, J.; Lieberman, H.R.; O’Brien, C.; Peck, J.; Tenenbein, M.; Weaver, C.; Harvey, S.; Urban, J.; Doepker, C. Systematic review of the potential adverse effects of caffeine consumption in healthy adults, pregnant women, adolescents, and children. Food Chem. Toxicol., 2017, 109(Pt 1), 585-648.
[http://dx.doi.org/10.1016/j.fct.2017.04.002] [PMID: 28438661]
[4]
Shikino, K.; Masuyama, T.; Yamashita, T.; Ikusaka, M. Allergic contact dermatitis following drug rash due to chlorpheniramine maleate. Clin. Case Rep., 2017, 5(5), 718-719.
[http://dx.doi.org/10.1002/ccr3.897] [PMID: 28469883]
[5]
Septimus, E.J.; Albrecht, H.H.; Solomon, G.; Shea, T.; Guenin, E.P. Extended-release guaifenesin/pseudoephedrine hydrochloride for symptom relief in support of a wait-and-see approach for the treatment of acute upper respiratory tract infections: a randomized, double-blind, placebo-controlled study. Curr. Ther. Res. Clin. Exp., 2017, 84, 54-61.
[http://dx.doi.org/10.1016/j.curtheres.2017.04.004] [PMID: 28761581]
[6]
Hammond, F.M.; Sauve, W.; Ledon, F.; Davis, C.; Formella, A.E. Safety, tolerability, and effectiveness of dextromethorphan/quinidine for pseudobulbar affect among study participants with traumatic brain injury: results from the prism-ii open label study. PM R, 2018, 10(10), 993-1003.
[http://dx.doi.org/10.1016/j.pmrj.2018.02.010] [PMID: 29477412]
[7]
Agostini, J.V.; Leo-Summers, L.S.; Inouye, S.K. Cognitive and other adverse effects of diphenhydramine use in hospitalized older patients. Arch. Intern. Med., 2001, 161(17), 2091-2097.
[http://dx.doi.org/10.1001/archinte.161.17.2091] [PMID: 11570937]
[8]
Dong, Y.; Chen, X.; Chen, Y.; Chen, X.; Hu, Z. Separation and determination of pseudoephedrine, dextromethorphan, diphenhydramine and chlorpheniramine in cold medicines by nonaqueous capillary electrophoresis. J. Pharm. Biomed. Anal., 2005, 39(1-2), 285-289.
[http://dx.doi.org/10.1016/j.jpba.2005.02.032] [PMID: 16085144]
[9]
Dong, Y.M.; Li, N.; An, Q.; Lu, N.W. A novel nonionic micellar liquid chromatographic method for simultaneous determination of pseudoephedrine hydrochloride, paracetamol, and chlorpheniramine in cold compound preparations. J. Liq. Chromatogr. Relat. Technol., 2015, 38(2), 251-258.
[http://dx.doi.org/10.1080/10826076.2014.903850]
[10]
Moreira, A.B.; Oliveira, H.P.M.; Atvars, T.D.Z.; Dias, I.L.T.; Neto, G.O.; Zagatto, E.A.G.; Kubota, L.T. Direct determination of paracetamol in powdered pharmaceutical samples by fluorescence spectroscopy. Anal. Chim. Acta, 2005, 539(1-2), 257-261.
[http://dx.doi.org/10.1016/j.aca.2005.03.012]
[11]
Harsono, T.; Yuwono, M.; Indrayanto, G. Simultaneous determination of some active ingredients in cough and cold preparations by gas chromatography, and method validation. J. AOAC Int., 2005, 88(4), 1093-1098.
[http://dx.doi.org/10.1093/jaoac/88.4.1093] [PMID: 16152925]
[12]
Qureshi, S.Z.; Saeed, A.; Rahman, N. Spectrophotometric method for the determination of acetaminophen in drug formulations by oxidative coupling with m-cresol. Chem. Anal., 1992, 37(2), 227-229.
[13]
Song, A.Y.; Wei, L.L.; Wang, J.K.; Zeng, J.L.; Shi, E.L. Determination of caffeine in cold medicine by hollow fiber liquid phase microextraction-gas chromatography. Chin. J. Health Lab. Technol, 2017, 27(13), 1834-1837.
[14]
de Castro Costa, B.M.; Marra, M.C.; da Costa Oliveira, T.; Munoz, R.A.A.; Batista, A.D.; do Lago, C.L.; Richter, E.M. Ultrafast capillary electrophoresis method for the simultaneous determination of ammonium and diphenhydramine in pharmaceutical samples. J. Sep. Sci., 2018, 41(14), 2969-2975.
[http://dx.doi.org/10.1002/jssc.201800273] [PMID: 29785728]
[15]
Avram, N.; Heghes, S.C.; Rus, L.L.; Juncan, A.M.; Rus, L.M.; Filip, L.; Filip, C.R. HPLC-UV determination of dextromethorphan in syrup method validation.Rev. Chim -Bucharest,, 2019, 70(2), 487-490.
[16]
Duan, X.Y.; Liu, X.F.; Dong, Y.; Zhang, J.; He, S.J.; Uhagaze, D.S.; Yang, F.T.; Dong, Y.M. A micellar HPLC method for simultaneous determination of six active ingredients in cold compound preparations. J. Liq. Chromatogr. Relat. Technol., 2019, 42(15-16), 485-493.
[http://dx.doi.org/10.1080/10826076.2019.1625375]
[17]
Dongala, T.; Katari, N.K.; Palakurthi, A.K.; Jonnalagadda, S.B. Development and validation of a generic RP-HPLC PDA method for the simultaneous separation and quantification of active ingredients in cold and cough medicines. Biomed. Chromatogr., 2019, 33(11)
[http://dx.doi.org/10.1002/bmc.4641] [PMID: 31265736]
[18]
Dong, Y.M. Pharmaceutical Analysis; Tsinghua University Press: Beijing, 2018.
[19]
Siddiqui, M.R.; AlOthman, Z.A.; Rahman, N. Analytical techniques in pharmaceutical analysis: a review. Arab. J. Chem., 2017, 10(1), S1409-S1421.
[http://dx.doi.org/10.1016/j.arabjc.2013.04.016]
[20]
AlOthman, Z.A.; Rahman, N.; Siddiqui, M.R. Review on pharmaceutical impurities, stability studies and degradation products: an analytical approach. Rev. Adv. Sci. Eng, 2013, 2(2), 155-166.
[http://dx.doi.org/10.1166/rase.2013.1039]
[21]
Rahman, N.; Azmi, S.N.H.; Wu, H.F. The importance of impurity analysis in pharmaceutical products: an integrated approach. Accredit. Qual. Assur., 2006, 11(1-2), 69-74.
[http://dx.doi.org/10.1007/s00769-006-0095-y]
[22]
El-Naggar, A.Y. Gas-liquid chromatographic study of thermodynamics of some alkanes on polysiloxane stationary phase. Petrol. Sci. Technol., 2006, 24(7), 753-767.
[http://dx.doi.org/10.1081/LFT-200044405]
[23]
Mario, E.; Meehan, L.G. Simultaneous determination of nonderivated phenylpropanolamine, glyceryl guaiacolate, chlorpheniramine, and dextromethorphan by gas chromatography. J. Pharm. Sci., 1970, 59(4), 538-540.
[http://dx.doi.org/10.1002/jps.2600590421] [PMID: 5440684]
[24]
Guo, X.; Qian, W.; Yang, C.; Zhu, X. Analysis of paracetamol, caffeine and chlorphenamine maleate in suxiaoshangfeng capsules by capillary gas chromatography. Se Pu, 1998, 16(2), 164-166.
[PMID: 11326986]
[25]
Chinese Pharmacopoeia Commission. Chinese Pharmacopoeia. 4th part; China Medical Science and Technology Press: Beijing, 2015;
[26]
Rahman, N.; Khan, S. Circular dichroism spectroscopy: a facile approach for quantitative analysis of captopril and study of its degradation. ACS Omega, 2019, 4(2), 4252-4258.
[http://dx.doi.org/10.1021/acsomega.8b03384] [PMID: 31459632]
[27]
Rahman, N.; Sameen, S.; Kashif, M. Spectroscopic study on the interaction of haloperidol and 2,4-dinitrophenylhydrazine and its application for the quantification in drug formulations. Anal. Chem. Lett., 2016, 6(6), 874-885.
[http://dx.doi.org/10.1080/22297928.2016.1265898]
[28]
Li, J.; Li, Z.H. HPLC determination of three components in compound acetaminophen caplets tablets. Yaowu Fenxi Zazhi, 2010, 30(8), 1510-1512.
[29]
Qi, M.L.; Wang, P.; Zhou, L.; Sun, Y. Simultaneous determination of four active components in a compound formulation by liquid chromatography. Chromatographia, 2003, 58(3-4), 183-186.
[30]
Hadad, G.M.; Mahmoud, W.M.M. The use of a monolithic column to improve the simultaneous determination of caffeine, paracetamol, pseudoephedrine, aspirin, dextromethorphan, chlorpheniramine in pharmaceutical formulations by HPLC–a comparison with a conventional reversed-phase silica-based column. J. Liq. Chromatogr. Relat. Technol., 2011, 34(20), 2516-2532.
[http://dx.doi.org/10.1080/10826076.2011.591031]
[31]
Suntornsuk, L. Separation of cold medicine ingredients by capillary electrophoresis. Electrophoresis, 2001, 22(1), 139-143.
[http://dx.doi.org/10.1002/1522-2683(200101)22:1<139:AID-ELPS139>3.0.CO;2-D] [PMID: 11197163]
[32]
Liu, Y.C.; Chang, S.W.; Chen, C.Y.; Chien, I.C.; Lin, C.H. Separation and determination of cold medicine ingredients by capillary zone electrophoresis using sulfated β-cyclodextrin as an electrolyte modifier and chiral selector. J. Chin. Chem. Soc. (Taipei), 2015, 62(2), 191-196.
[http://dx.doi.org/10.1002/jccs.201400276]
[33]
Lou, H.G.; Yuan, H.; Ruan, Z.R.; Jiang, B. Simultaneous determination of paracetamol, pseudoephedrine, dextrophan and chlorpheniramine in human plasma by liquid chromatography-tandem mass spectrometry. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 2010, 878(7-8), 682-688.
[http://dx.doi.org/10.1016/j.jchromb.2010.01.005] [PMID: 20133213]

Rights & Permissions Print Cite
Article Metrics
47
1
© 2024 Bentham Science Publishers | Privacy Policy