Main Article Content
Abstract
RP-UPLC method was developed and validated for the determination of chlorpheniramine maleate and dextromethorphan hydrobromide in tablet dosage form. Reverse phase waters acquity UPLC BEH C18 (50 mm × 2.1 mm, 1.7 μm) column using isocratic mobile phase of 0.5 mL 0.1% TFA (trifluroacetic acid) in H2O:CH3CN (70:30 %v/v). The flow rate was 0.2 mL/min and 252 nm wavelength use for detection on PDA detector. The retention time of chlorpheniramine maleate was 1.2 min and 2.2 min for dextromethorphan hydrobromide. Chlorpheniramine maleate and dextromethorphan hydrobromide was subjected to stress conditions including acidic, alkaline, oxidation, photolysis and thermal degradation. The method was validated as per ICH guideline with respect to samples to specificity, precision, accuracy, linearity and robustness.
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References
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References
A. Siu and R. Drachtman, Dextromethorphan: A Review of N-methyl-D-aspartate Receptor Antagonist in the Management of Pain, CNS Drug Rev., 13, 96 (2013); https://doi.org/10.1111/j.1527-3458.2007.00006.x
F.E. Simons, Advances in H1-Antihistamines, N. Engl. J. Med., 351, 2203 (2004); https://doi.org/10.1056/NEJMra033121
I.M. Paul, J. Beiler, A. McMonagle, M.L. Shaffer, L. Duda and C.M. Berlin Jr., Effect of Honey, Dextromethorphan, and No Treatment on Nocturnal Cough and Sleep Quality for Coughing Children and Their Parents, Arch. Pediatr. Adolesc. Med., 161, 1140 (2007); https://doi.org/10.1001/archpedi.161.12.1140
P.W. Carr, Xiaoli Wang and D.R. Stoll, The Effect of Pressure, Particle Size and Time on Optimizing Performance in LC, Anal. Chem., 81, 5342 (2009); https://doi.org/10.1021/ac9001244
Y. Wu, J.R. Engen and W.B. Hobbins, Ultra Performance Liquid Chromatography (UPLC) Further Improves Hydrogen/Deuterium Exchange Mass Spectrometry, J. Am. Soc. Mass Spectrom., 17, 163 (2006); https://doi.org/10.1016/j.jasms.2005.10.009
G. Chawla and C. Ranjan, Principle, Instrumentation and Applications of UPLC: A Novel Technique of Liquid Chromatography, Open Chem. J., 3, 1 (2016); https://doi.org/10.2174/1874842201603010001
M. Bakshi and S. Singh, Development of Validated Stability-Indicating Assay Methods-Critical Review, J. Pharm. Biomed. Anal., 28, 1011 (2002); https://doi.org/10.1016/S0731-7085(02)00047-X
M. Blessy, R.D. Patel, P.N. Prajapati and Y.K. Agrawal, Development of Forced Degradation and Stability Indicating Studies of Drugs-A Review, J. Pharm. Anal., 4, 159 (2014); https://doi.org/10.1016/j.jpha.2013.09.003
B. Sirigiri, P. Chengalva, S.A. Parameswari and G. Aruna, A Novel HPLC Method for the Simultaneous Determination of Chlorpheniramine Maleate and Dextromethorphan in Bulk and Pharmaceutical Formula-tion, Int. J. Pharm. Sci. Res., 1447 (2018); https://doi.org/10.13040/IJPSR.0975-8232.9(3).1147-51
A.U. Din, H. Shafi, M. Imran, M. Sarwar, M.A. Tahir and S. Khursheed, Validated Reversed-Phase Liquid Chromatographic Method for Simultaneous Determination of Dextromethorphan and Chlorphenir-amine in Non-Biological and Biological Matrices Using PDA Detector, Pharm. Anal. Acta, 9, 1 (2018); https://doi.org/10.4172/2153-2435.1000590
N. Al-Shaalan, Simultaneous Determination of Chlorphineramine Maleate, Dextromethorphan HBr and Phenylephrin HCl in Codilar Syrup using High Performance Liquid Chromatography, J. Pharm. Sci. Innov., 1, 29 (2012).
S.A. Kumar, M. Debnath and D. Vimala, Simultaneous Estimation of Phenylephrine HCl, Chlorpheniramine Maleate and Dextromethorphan HBr in a Pharmaceutical (Syrup) Formulations by RP-HPLC using PDA detector, Pak. J. Pharm. Res., 2, 89 (2016); https://doi.org/10.22200/pjpr.2016289-97
V. Jain and M.C. Sharma, Validated RP-HPLC Method for Determining the Levels of Bromhexine HCl, Chlorpheniramine Maleate, Dextro-methorphan HBr and Guaiphenesin in their Pharmaceutical Dosage Forms, J. Talibah Univ. Sci., 10, 38 (2016); https://doi.org/10.1016/j.jtusci.2015.02.019)
F. Al-Rimawi, Normal-phase LC Method for Simultaneous Analysis of Pseudophedrine Hydrochloride, Dextromethorphan Hydrobromide, Chlorpheniramine Maleate and Paracetamol in Tablet Formulations, Saudi Pharm. J., 18, 103 (2010); https://doi.org/10.1016/j.jsps.2010.02.006
R.S. Latti, N. Jivani, D. Kumar, B. Patel and D. Sheth, Simultaneous Estimation of Paracetamol, Cetrizine Hydrochloride, Chlorpheniramine Maleate and Dextromethorphan Hydrobromide in Solid Dosage form by High Performance Liquid Chromatography. Inventi Rapid- Pharm Anal. Qual.. 1024/13 (2013).
R. Heydari, A New HPLC Method for the Simultaneous Determination of Acetaminophen, Phenylephrine, Dextromethorphan and Chlorphenir-amine in Pharmaceutical Formulations, Anal. Lett., 41, 965 (2008); https://doi.org/10.1080/00032710801978137
T. Goyal, A Novel Stability Indicating HPLC Method for Simultaneous Estimation of Guaiphenesin, Chlorpheneramine Maleate & Dextro-methorphan HBr, Int. J. Pharm. Sci. Res., 4, 4435 (2013); https://doi.org/10.13040/IJPSR.0975-8232.4(11).4435-41
K.D. Khalode, S.B. Waikar and S.P. Padmane, A Validated UV Spectro-photometric Method for the Simultaneous Estimation of Dextromethorphan Hydrobromide and Chlorpheniramine Maleate in Syrup Formulation, Int. J. Pharm. Technol., 4, 4690 (2012).
E. Mario and L.G. Meehan, Simultaneous Determination of Nonderivatized Phenylpropanolamine, Glyceryl Guaiacolate, Chlorpheniramine and Dextromethorphan by Gas Chromatography, J. Pharm. Sci., 59, 538 (1969); https://doi.org/10.1002/jps.2600590421
H.M. Heneedaka, S. Ismail, S. Mostafab, E.K. Ehab and M.E. Sadekd, Development and Validation of a Sensitive UHPLC-MS/MS Method for the Simultaneous Analysis of Tramadol, Dextromethorphan Chlor-pheniramine and their Major Metabolites in Human Plasma in Forensic Context: Application to Pharmacokinetics, Biomed. Chromatogr., 29, 998 (2014); https://doi.org/10.1002/bmc.3384
Y. Ding, K. Huang, L. Chen, J. Yang, W.-Y. Xu, X.-J. Xu, R. Duan, J. Zhang and Q. He, Simultaneous Quantitative Analysis of Dextromethor-phan, Dextrorphan and Chlorphenamine in Human Plasma by Liquid Chromatography-Electrospray Tandem Mass Spectrometry, Biomed. Chromatogr., 28, 446 (2014); https://doi.org/10.1002/bmc.3054
ICH-Harmonized Tripartite Guideline, Stability Testing of New drug Substance and Products Q1A (R2), International Conference on Harmonization, IFPMA, Geneva, Swizerland (2003).
ICH-Harmonized Tripartite Guideline, Validation of Analytical Procedures: text and methodology Q2 (R1), International Conference on Harmonization, IFPMA, Geneva,Switzerland (2005).