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Quantitation of Guaifenesin (Glyceryl Guaiacolate) in Syrup and Spiked Human Plasma using HPLC with Diode Array Detection
Corresponding Author(s) : Aysel Kucuk Tunca
Asian Journal of Chemistry,
Vol. 29 No. 10 (2017): Vol 29 Issue 10
Abstract
A new, simple and rapid reverse phase-high performance liquid chromatography-diode array detection (RP-HPLC-DAD) method has been developed using sibutramin (S) as internal standard for quantitative determination of guaifenesin (G) and validated both in syrup dosage forms and spiked human plasma samples. The analysis was carried out within 10 min on Inertsil C18 column using isocratic mobile phase consists of phosphate buffer and methanol with pH 3 (60:40, v/v) at a flow-rate of 1 mL min-1 and detection at 212 nm. The concentration-response relationship was linear over a concentration range of 10-100 μg mL-1 for guaifenesin. The developed liquid chromatographic method was successfully applied for the routine analysis of guaifenesin in a cough syrup and human plasma samples without liquid-liquid extraction for quality control purposes. After the method development, bioanalytical method validation was applied. For this purpose, all the validation parameters such as intra-day and inter-day precisions, accuracy, specificity, selectivity and recovery were determined. After the validation procedure, the results were evaluated statistically.
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- United States Pharmacopoeia, 25th Review, The National Formulary, 19th Review, The United States Pharmacopoeia Convention, Rockville, MD, USA, p. 975 (2002).
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References
United States Pharmacopoeia, 25th Review, The National Formulary, 19th Review, The United States Pharmacopoeia Convention, Rockville, MD, USA, p. 975 (2002).
J.E.F. Reynolds, Erythromycin, In: Martindale: The Extra Pharmacopoeia, The Pharmaceutical Press. London, edn 33 (2002).
The United States Pharmacopedia (25th Revision), United States Pharmacopeial Convention, Rockville, MD, USA (2002).
E.F. Elkady, Talanta, 82, 1604 (2010); https://doi.org/10.1016/j.talanta.2010.07.024.
J. Holmalahti, Pharmazie, 52, 640 (1997).
L.A. Shervington, Anal. Lett., 30, 927 (1997); https://doi.org/10.1080/00032719708002307.
G.W. Schieffer and D.E. Hughes, J. Pharm. Sci., 72, 55 (1983); https://doi.org/10.1002/jps.2600720113.
T.D. Wilson, W.G. Jump, W.C. Neumann and T.S. Martin, J. Chromatogr. A, 641, 241 (1993); https://doi.org/10.1016/0021-9673(93)80140-4.
L. Carnevale, J. Pharm. Sci., 72, 196 (1983); https://doi.org/10.1002/jps.2600720227.
A. Ozdemir, H. Aksoy, E. Dinc, D. Baleanu and S. Dermis, Rev. Roum. Chim., 51, 117 (2006).
G. Grosa, E.D. Grosso, R. Russo and G. Allegrone, J. Pharm. Biomed. Anal., 41, 798 (2006); https://doi.org/10.1016/j.jpba.2006.01.026.
M. Ansari, M. Kazemipour and M. Shahriar, Iranian J. Pharmacol. Therap., 5, 67 (2006).
T.M. Chen, J.R. Pacifico and R.E. Daly, J. Chromatogr. Sci., 26, 636 (1988); https://doi.org/10.1093/chromsci/26.12.636.
W.O. McSharry and I.V.E. Savage, J. Pharm. Sci., 69, 212 (1980); https://doi.org/10.1002/jps.2600690227.
V. Galli and C. Barbas, J. Chromatogr. A, 1048, 207 (2004); https://doi.org/10.1016/S0021-9673(04)01210-5.
S.M. Amer, S.S. Abbas, M.A. Shehata and N.M. Ali, J. AOAC Int., 91, 276 (2008).
K.L. Narasimha Rao, Ch. Krishnaiah, K.S. Babu and K.P. Reddy, J. Saudi Chem. Soc., 18, 593 (2014); https://doi.org/10.1016/j.jscs.2012.01.006.
N. Muhammad and J.A. Bodnar, J. Liq. Chromatogr., 3, 113 (1980); https://doi.org/10.1080/01483918008060158.
S. Stavchansky, S. Demirbas, L. Reyderman and C.-K. Chai, J. Pharm. Biomed. Anal., 13, 919 (1995); https://doi.org/10.1016/0731-7085(95)01506-G.
J.B. Aluri and S. Stavchansky, J. Pharm. Biomed. Anal., 11, 803 (1993); https://doi.org/10.1016/0731-7085(93)80072-9.
V. Pade and S. Stavchansky, Anal. Lett., 26, 867 (1993); https://doi.org/10.1080/00032719308019870.
X. Chen, J. Huang, Z. Kong and D. Zhong, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 817, 263 (2005); https://doi.org/10.1016/j.jchromb.2004.12.011.
E. Imamoglu and A.K. Tunca, J. Liq. Chromatogr. Rel. Technol., 37, 1039 (2014); https://doi.org/10.1080/10826076.2013.765459.
T.H. Eichhold, D.L. McCauley-Myers, D.A. Khambe, G.A. Thompson and S.H. Hoke, J. Pharm. Biomed. Anal., 43, 586 (2007); https://doi.org/10.1016/j.jpba.2006.07.018.
H. Patil, S. Sonawane and P. Gide, J. Anal. Chem., 69, 390 (2014); https://doi.org/10.1134/S1061934814040030.
R.M. Gudipati, J.E. Wallace and S.A. Stavchansky, Anal. Lett., 24, 265 (1991); https://doi.org/10.1080/00032719108052902.
Review Guidance: Validation of Chromatographic Methods; Centre for Drug Evaluation and Research (CDER), Food and Drug Administration, November (1994).
ICH, Validation of Analytical Procedures: Text and Methodology, Step 4 Version (2005).