A rapid and sensitive CZE (Capillary Zone Electrophoresis) method for pharmaceutical analysis was developed and fully validated. The active compounds: Pseudoephedrine hydrochloride (PSE), Triprolidine hydrochloride (TRI) and Paracetamol (PAR) were separated and quantitatively determined using the tris-borate 30 mM buffer at pH = 9.0 as a Background Electrolyte (BGE). The electrophoretic separation was carried out at 25 kV in an unmodified fused silica capillary of I.D. = 50 μm with a “bubble-cell” for UV detection at 210 nm and 25°C. The separation was reached in about 3 min. After calibration the method was applied for analysis of three commercially available pharmaceutical preparations. The repeatability (RSD%) of migration time (tm) was ranging between 0.47% and 0.90% and of peak areas (A) between 0.63% and 3.64%. The Limit of Detection (LOD) values was of 0.19 μg/mL, 0.31 μg/mL and 0.08 μg/mL for respectively PSE, TRI and PAR. The results obtained in this study showed that the proposed method was useful in routinely analysis of pharmaceuticals.
References
[1]
Zhan, Y., Zhang, Y., Li, Q. and Du, X. (2011) Selective Spectrophotometric Determination of Paracetamol with Sodium Nitroprusside in Pharmaceutical and Biological Samples. Journal of Analytical Chemistry, 66, 215-220. http://dx.doi.org/10.1134/S1061934811020171
[2]
Nagendra, P. (2011) Spectrophotometric Estimation of Paracetamol in Bulk and Pharmaceuticeutical Formulations. Journal of Chemistry, 8,149-152.
[3]
Sequinel, R., Rufino, J.L., Pezza, H.R. and Pezza, L. (2011) Spectrophotometric Determination of Paracetamol in Pharmeceuticals Using Microwave-Assisted Hydrolysis and a Micellar Medium. Latin American Journal of Pharmacy, 30, 1330-1335.
[4]
Atta, N.F., Galal, A., Abu-Attia, F.M. and Azab, S.M. (2011) Simultaneous Determination of Paracetamol and Neuro-transmitters in Biological Fluids Using a Carbon Paste Sensor Modified with Gold Nanoparticles. Journal of Materials Chemistry, 21, 13015-13024. http://dx.doi.org/10.1039/c1jm11795e
[5]
Hegazy, M.A., Khattab, F.E. and Abdelhameed, B.M. (2013) Validated Chromatographic Methods for Determination of Paracetamol, Pseudoephedrine and Cetrizine in Pharmaceutical Formulations. Analytical Chemistry: An Indian Journal, 12, 248-255.
[6]
Khedkar, A.N., Rakh, M.S. and Rao, J.R. (2012) RP-HPLC Method Development and Validation for the Simultaneous Estimation of Levocetrizine, Pseudoephedrine and Ambroxol in Bulk and in Tablets. Journal of Pharmacy Research, 5, 2949-2953.
[7]
Rawool, N.D., Venkatchalam, A. and Singh, K.H. (2013) Development and Validation of a Rapid RP-HPLC Method for the Simultaneous Estimation of Cetrizine and Pseudoephedrine in Pharmaceutical Dosage Forms. International Journal of Current Pharmaceutical Research, 5, 54-60.
[8]
Akhtar, M.J., Khan, S. and Salam, K.M.A. (1993) High Performance Liquid Chromatographic Assay for the Determination of Paracetamol, Pseudoephedrine HCl and Triprolidine HCl in Pharmaceutical Preparations. Pakistan Journal of Pharmaceutical Sciences, 6, 29-34.
[9]
Akhtar, M.J., Khan S. and Hafiz M. (1994) High-Performance Liquid Chromatographic Assay for the Determination of Paracetamol, Pseudoephedrine Hydrochloride and Triprolidine Hydrochloride. Journal of Pharmaceutical and Biomedical Analysis, 12, 379-382. http://dx.doi.org/10.1016/0731-7085(94)90014-0
[10]
De Orsi, D., Gagliardi, L., Bolasco, A. and Tonelli, D. (1996) Simultaneous Determination of Triprolidine, Pseudoephedrine, Paracetamol and Dextromethorphan by HPLC. Chromatographia, 43, 496-500. http://dx.doi.org/10.1007/BF02293000
[11]
Manassra, A., Khamis, M., El-Dakiki, M., Abdel-Qader, Z. and Al Rimawi, F. (2010) Simultaneous HPLC Analysis of Pseudoephedrine Hydro-chloride, Codeine Phosphate and Triprolidine Hydrochloride in Liquid Dosage Form. Journal of Pharmaceutical and Biomedical Analysis, 51, 991-993. http://dx.doi.org/10.1016/j.jpba.2009.10.024
[12]
Vignaduzzo, S.E. and Kaufman, T.S. (2013) Development and Validation of a HPLC Method for the Simultaneous Determination of Bromexine, Chlorpheniramine, Paracetamol and Pseudoephedrine in Their Combined Cold Medicine Formulations. Journal of Liquid Chromatography & Related Technologies, 36, 2829-2843. http://dx.doi.org/10.1080/10826076.2012.717055
[13]
Jiang, J., Yang, R.-Y., Ren, J.B., Zhou, Y.-S. and Li, N. (2012) Simultaneous Determination of the Contents of Five Ingredients in Paracetamol, Triprolidine Hydrochloride and Pseudoephedrine Hydrochloride Tablets by Microemulsion Liquid Chromatography. Shenyang Yaoke Dexue Xuebao, 29, 456-461.
[14]
Xuan, X., Huang, L., Pan, X. and Li, N. (2013) Simultaneous Determination of Five Cold Medicine Ingredients in Paracetamol, Triprolidine Hydrochloride and Pseudoephedrine Hydrochloride Tablets by pH/Organic Solvent Double-Gradient High Performance Liquid Chromatography. Sepu, 31, 133-138. http://dx.doi.org/10.3724/SP.J.1123.2012.09023
[15]
El Gindy, A., Attia, K.A.-S., Nassar, M.W., Abu Seada, H.H. and Al-Shabrawi Shoeib, M. (2013) HPLC Method for Determination of Paracetamol, Pseudoephedrine, Triprolidine, Methylparaben, Propylparaben, Sodium Benzoate and Their Related Substances in Pharmaceutical Syrup. J. of Liquid Chromatogr. & Related Technol., Journal of Liquid Chromatography & Related Technologies, 36, 1251-1263.
[16]
Zhang, L., Hu, Q., Chen, G.N. and Fang, Y.Z. (2000) Simultaneous Determination of the Active Ingredients in Composite Pseudoephedrine Hydrochloride Tablets by Capillary Electrophoresis. Analytica Chimica Acta, 424, 257-262. http://dx.doi.org/10.1016/S0003-2670(00)01117-X
[17]
Solangi, A.R., Bhanger, M.I., Memon, S., Khuhawar, M.Y. and Mallah, A. (2009) A Capillary Zone Electrophoretic Method for Simultaneous Determination of Seven Drugs in Pharmaceuticals and in Human Urine. Journal of AOAC International, 5, 1382-1389.
[18]
Capella-Peiro, M.-E., Bose, D., Rubert, M.F. and Esteve-Romero, J. (2006) Optimization of a Capillary Zone Electro-phoresis Method by Using a Central Composite Factorial Design for the Determination of Codeine and Paracetamol in Pharmaceuticals. Journal of Chromatography B, 839, 95-101. http://dx.doi.org/10.1016/j.jchromb.2006.04.023
[19]
Liu, X.M., Liu, L.H., Chen, H.L. and Chen, X.G. (2007) Separation and Determination of Five Active Components in Medicinal Preparations by Flow Injection-Capillary Elec-trophoresis. Journal of Pharmaceutical and Biomedical Analysis, 43, 1700-1705.
[20]
Rambla-Alegre, M., Peris-Vicente, J., Esteve-Romero, J., Capella-Peiro, M.-E. and Bose, D. (2010) Capillary Electrophoresis Determination of Antihistamines in Serum and Pharmaceuticals. Analytica Chimica Acta, 666, 102-109. http://dx.doi.org/10.1016/j.aca.2010.03.041
[21]
ICH (2005) Harmonized Tripartite Guideline, Validation of Analytical Procedures: Text and Metodology Q2(R1).