Development and validation of a generic RP-HPLC PDA method for the simultaneous separation and quantification of active ingredients in cold and cough medicines.
OTC
RP-HPLC
cold and cough
method development
validation
Journal
Biomedical chromatography : BMC
ISSN: 1099-0801
Titre abrégé: Biomed Chromatogr
Pays: England
ID NLM: 8610241
Informations de publication
Date de publication:
Nov 2019
Nov 2019
Historique:
received:
30
05
2019
accepted:
28
06
2019
pubmed:
3
7
2019
medline:
16
1
2020
entrez:
3
7
2019
Statut:
ppublish
Résumé
A novel generic reverse phase high performance liquid chromatography (RP-HPLC) method is developed and validated for simultaneous determination of seven pharmaceutically active ingredients, namely, acetaminophen, dextromethorphan, doxylamine, phenylephrine, guaifenesin, caffeine and aspirin. All seven ingredients were quantified in soft gel, syrup and tablet formulations of the over-the-counter US-marketed products, as per the guidelines of the International Conference on Harmonization. The separation was achieved in a 16 min run time on an Agilent Zorbax Phenyl column using a gradient method with two mobile phases. Mobile phase A was 0.15% trifluoro acetic acid in purified water and while mobile phase B was a mixture of acetonitrile and methanol (750:250 v/v) with 0.02% trifluoro acetic acid. The flow rate was 1.0 mL min
Substances chimiques
Multi-Ingredient Cold, Flu, and Allergy Medications
0
Respiratory System Agents
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e4641Informations de copyright
© 2019 John Wiley & Sons, Ltd.
Références
Abdelkawy, M., Metwaly, F., El Raghy, N., Hegazy1, M., & Fayek, N. (2011). Simultaneous determination of ambroxol hydrochloride and guaifenesin by HPLC, TLC spectrodensitometric and multivariate calibration methods in pure form and in cough-cold formulations. Journal of Chromatography and Separation Techniques, 2, 112.
Ali, M. S., Ghori, M., Rafiuddin, S., & Khatri, A. R. (2007). A new hydrophilic interaction liquid chromatographic (HILIC) procedure for the simultaneous determination of pseudoephedrine hydrochloride (PSH), diphenhydramine hydrochloride (DPH) and dextromethorphan hydrobromide (DXH) in cough-cold formulations. Journal of Pharmaceutical and Biomedical Analysis, 43, 158-167. https://doi.org/10.1016/j.jpba.2006.06.038
Bankar, A. A., Lokhande, S. R., Sawant, R. L., & Ankita, R. B. (2013). Spectrophotometric estimation of guaifenesin and salbutamol in pure and tablet dosage form by using different methods. Der Pharma Chemica., 5, 92-97.
Burge, L. J., & Raches, D. W. (2003). A rapid HPLC assay for the determination of dextro-propoxyphene related substance in combination with aspirin, acetaminophen, and caffeine in tablet and capsule formulations. Journal of Liquid Chromatography, 26, 1977-1990. https://doi.org/10.1081/JLC-120021765
Çaglar, H., & Büyüktuncel, E. (2014). HPLC method development and validation:simultaneous determination of active ingredients in cough and cold pharmaceuticals. International Journal of Pharmacy and Pharmaceutical Sciences, 6, 421-428.
Dinc, E., Baleanu, D., & Onur, F. (2002). Simultaneous spectrophotometric analysis of codeine phosphate, acetylsalicylic acid and caffeine in tablets by inverse least-squares and principal component regression techniques. Analytical Letters, 35, 545-558. https://doi.org/10.1081/AL-120002686
Dong, Y., Chen, X., Chen, Y., Chen, X., & Hu, Z. (2005). separation and determination of pseudoephedrine, dextromethorphan, diphenhydramine and chlorpheniramine in cold medicines by nonaqueous capillary electrophoresis. Journal of Pharmaceutical and Biomedical Analysis, 39, 285-289. https://doi.org/10.1016/j.jpba.2005.02.032
El-Gindy, A., Emara, S., Mesbah, M. K., & Ghada, M. H. (2006). New validated methods for the simultaneous determination of two multicomponent mixtures containing guaiphenesin in syrup by HPLC and chemometrics assisted UV spectroscopy. Analytical Letters, 39, 2699-2723. https://doi.org/10.1080/00032710600824821
El-Gindy, A., Emara, S., & Mostafa, A. (2006). Application and validation of chemometrics assisted spectrophotometry and liquid chromatography for the simultaneous determination of sixcomponent pharmaceuticals. Journal of Pharmaceutical and Biomedical Analysis, 41, 421-430. https://doi.org/10.1016/j.jpba.2005.12.005
Ezhava, S. B., Bhalara, K. D., Rathod, I. S., & Dolarrai, D. B. (2014). Simultaneous estimation of salbutamol sulphate and guaiphenesin in their combined liquid dosage form by HPTLC method. International Journal of Pharma Research and Health Sciences, 2, 191-196.
Golubitskii, G. B., Budko, E. V., Basova, E. M., Ivanov, V. M., & Kostarnoi, A. V. (2007). Chromatographic separation of paracetamol, caffeine, and aspirin on an adsorbent with immobilized nitrile groups and the analysis of askofen p tablets. Journal of Analytical Chemistry, 62, 571-574. https://doi.org/10.1134/S1061934807060135
Grosa, G., Grosso, E. D., Russo, R., & Allegrone, G. (2006). Simultaneous, stability indicating, HPLC- DAD determination of guaifenesin and methyl and propyl-parabens in cough syrup. Journal of Pharmaceutical and Biomedical Analysis, 41, 798-803. https://doi.org/10.1016/j.jpba.2006.01.026
Harsono, T., Yuwono, M., & Indrayanto, G. (2005). Simultaneous determination of some active ingredients in cough and cold preparations by gas chromatography and method validation. Journal of AOAC International, 88, 1093-1098.
Heydari, R. (2008). A new HPLC method for the simultaneous determination of acetaminophen, phenylephrine, dextromethorphan and chlorpheniramine in pharmaceutical formulations. Analytical Letters, 41, 965-976. https://doi.org/10.1080/00032710801978137
--> International conference on harmonization. (2005) ICH Q2 (R1): Validation of analytical procedures: Text and methodology. ICH Secretariat, Geneva.
Kamatham, S. S., Kolli, S., Joga, D. D., Kumari, R. V., & Bharathi, D. Y. (2013). Simultaneous estimation of salbutamol, ambroxol and guaifenesin in tablet tosage forms by using RP-HPLC. International Journal of Pharmaceutical Research and Biomedical Analysis., 2, 01-13.
Korany, M. A., Fahmy, O. T., Mahgoub, H., & Hadir, M. M. (2011). High performance liquid chromatographic determination of some guaiphenesin-containing cough-cold preparations. Journal of Advanced Research, 2, 121-130. https://doi.org/10.1016/j.jare.2010.09.005
Ozdemir, A., Aksoy, H., Dinc, E., Dumitru, B., & Saadet, D. (2006). Determination of guaifenesin and dextromethorphan in a cough syrup by HPLC with fluorometric detection. Revue Roumaine de Chimie, 51, 117-122.
Paciolla, M. D., Jansen, S. A., Martellucci, S. A., & Osei, A. A. (2001). A fast and efficient determination of amines and preservatives in cough and cold liquid and suspension formulations using a single isocratic ion-pairing high power liquid chromatography method. Journal of Pharmaceutical and Biomedical Analysis, 26, 143-149. https://doi.org/10.1016/S0731-7085(01)00401-0
Palabiyik, I. M., & Onur, F. (2007). The simultaneous determination of phenylephrine hydrochloride, paracetamol, chlorpheniramine maleate and dextromethorphan hydrobromide in pharmaceutical preparations. Chromatographia, 66, S93-S96.
Qi, M., Wang, P., Zhou, L., & Yan, S. (2003). Simultaneous determination of four active components in a compound formulation by liquid chromatography. Chromatographia, 58, 183-186.
Raghava, R. T. V., Anil, K. N., Raja, K. S., Annarapu, M. R., Nittala, S. R., & Ivaturi, M. R. (2013). Development and validation of a stability-indicating RP-HPLC method for the simultaneous estimation of guaifenesin and dextromethorphan impurities in pharmaceutical formulations. Chromatography Research International, 2013, 1-12. https://doi.org/10.1155/2013/315145
Ramos-Martos, N., Aguirre-Gomez, F., Molina-Diaz, A., & Capitán-Vallvey, L. F. (2001). Application of liquid chromatography to the simultaneous determination of acetylsalicylic acid, caffeine, codeine, paracetamol, pyridoxine, and thiamine in pharmaceutical preparations. Journal of AOAC International, 84, 676-683.
Sagathiya, K., & Bagada, H. (2014). Development and validation of RPHPLC and HPTLC method of analysis for simultaneous estimation of ambroxol HCL, dextromethorphan HBR and guaifenesin and statistical comparison of developed methods. International Journal of Pharmacy and Pharmaceutical Sciences, 6, 312-316.
Sawyer, M., & Kumar, V. A. (2003). Rapid high-performance liquid chromatographic method for the simultaneous quantitation of aspirin, salicylic acid, and caffeine in effervescent tablets. Journal of Chromatographic Science, 41, 393-397. https://doi.org/10.1093/chromsci/41.8.393
Sena, M. M., Poppi, R. J., & N-way, P. L. S. (2004). Applied to simultaneous spectrophotometric determination of acetylsalicylic acid, paracetamol and caffeine. Journal of Pharmaceutical and Biomedical Analysis, 34, 27-34. https://doi.org/10.1016/j.japna.2003.08.011
Sun, S. F., Lui, G. R., & Wang, Y. H. (2006). Simultaneous determination of acetaminophen, caffeine, and chlorphenamine maleate in paracetamol and chlorphenamine maleate granules. Chromatographia, 64, 719-724. https://doi.org/10.1365/s10337-006-0093-6
Suneetha, G., Venkateswarlu, P., & Prasad, P. S. S. (2012). Determination of guaifensen and dextromethorphan by UPLC. Der Pharma Chemica., 4, 1019-1025.
Walode, S. G., Deshpande, S. D., & Deshpande, A. V. (2013). Stability indicating RP-HPLC method for simultaneous estimation of salbutamol sulphate and guaifenesin. Der Pharmacia Sinica., 4, 61-67.