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Validated Stability Indicating HPLC Method for Simultaneous Quantification of Trithioparamethoxy Phenylpropene and Chlorpheniramine Maleate in Tablet Forms
Corresponding Author(s) : N. Madhavi
Asian Journal of Chemistry,
Vol. 32 No. 6 (2020): Vol 32 Issue 6
Abstract
A novel easy stability indicating high performance liquid chromatography method has been developed for the concurrent assessment of trithioparamethoxy phenylpropene in combination with chlorpheniramine maleate using Luna C8 column with UV detection at 224 nm. The mobile phase comprised of 0.02 N phosphate buffer (pH 5.5) and acetonitrile (55:45 v/v) was delivered with a flow rate of 1.5 mL/min. The method was linear over the concentration range 6.25-18.75 μg/mL (trithioparamethoxy phenylpropene) and 1.5-4.5 μg/mL (chlorpheniramine maleate). The limit of quantification was 1.57 μg/mL (trithioparamethoxy phenylpropene) and 0.969 μg/mL (chlorpheniramine maleate). The calculated recoveries were 100.083-100.287% (trithioparamethoxy phenylpropene) and 99.827-100.277% (chlorpheniramine maleate). Trithioparamethoxy phenylpropene and chlorpheniramine maleate were subjected to forced stress like acid hydrolysis, base hydrolysis, thermal and oxidation degradation. The drugs were found to degrade in the applied conditions. The degraded products were resolved effectively from the trithioparamethoxy phenylpropene and chlorpheniramine maleate. The suggested stability-indicating HPLC method can be used for the quantitative evaluation of trithioparamethoxy phenylpropene and chlorpheniramine maleate in bulk medications and tablet formulations.
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- G.A. Jalbani, K. Aamir, A.M. Shaikh, M.A. Unar, R. Ashraf and F.M. Soomro, J. Pak. Med. Assoc., 54, 556 (2004).
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- P. Assanasen and R.M. Naclerio, Clin. Allergy Immunol., 17, 101 (2002).
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- S.N.H. Azmi, S.S.K. Al-Hadhrami, B.M.R. Al-Marhoubi, S.S.S. AlSulaimi and Z.D.S. Al-Shamoosi, J. Mol. Liq., 243, 750 (2017); https://doi.org/10.1016/j.molliq.2017.08.081
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- G. Ngwa, Drug Deliv. Technol., 10, 56 (2010).
- R. Singh and Z. Rehman, J. Pharm. Educ. Res., 3, 54 (2012).
- S.B. Kanthale, S.S. Thonte and B.B. Supekar, Int. J. Pharm. Sci. Res., 10, 1625 (2019).
- International Conference on the Harmonization, ICH Harmonized Tripartite Guideline, Stability Testing of New Drug Substances and Products Q1A (R2) (2003).
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References
G.A. Jalbani, K. Aamir, A.M. Shaikh, M.A. Unar, R. Ashraf and F.M. Soomro, J. Pak. Med. Assoc., 54, 556 (2004).
J.M. Serra-Grabulosa, M. Sánchez-Turet and C. Grau, Rev. Neurol., 34, 1178 (2002).
W. Xu, S. Xia, J. Pu, Q. Wang, P. Li, L. Lu and S. Jiang, Front. Microbiol., 9, 2643 (2018); https://doi.org/10.3389/fmicb.2018.02643
P. Assanasen and R.M. Naclerio, Clin. Allergy Immunol., 17, 101 (2002).
F. Kalpaklioglu and A. Baccioglu, Antiinflamm. Antiallergy Agents Med. Chem., 11, 230 (2012); https://doi.org/10.2174/1871523011202030230
S. Sharma, Trithioparamethoxy Phenylpropene. 1mg.com. Accessed on October 2019. Available at: https://www.1mg.com/generics/trithioparamethoxy-phenylpropene-211206.
Trithioparamethoxy Phenylpropene - Uses, Side-effects, Reviews, and Precautions. Tabletwise. Accessed on October 2019. Available at: https://www.tabletwise.com/medicine/trithioparamethoxy-phenylpropene.
M.D. Sadullah and V. Chauhan, Trithioparamethoxy Phenylpropene information. Myupchar. Accessed on October 2019. Available at: https://www.myupchar.com/en/medicine/trithioparamethoxy-phenylpropenep37141776#benefits.
A.A. Hepasulffol, Health potlio. Accessed on October 2019. Available at: http://healthpotli.com/productdetails.aspx?q=P00006863.
A.A. Hepasulfol, 12.5 mg/3 mg Tablet. 1mg.com. Accessed on October 2019. Available at: https://www.1mg.com/drugs/hepasulfol-aa-12.5-mg-3-mg-tablet-120158.
P. Valderrama, A.L. Romero, P.M. Imamura, I.R.S. Magalhães, P.S. Bonato and R.J. Poppi, Anal. Bioanal. Chem., 397, 181 (2010); https://doi.org/10.1007/s00216-010-3472-7
S.N.H. Azmi, S.S.K. Al-Hadhrami, B.M.R. Al-Marhoubi, S.S.S. AlSulaimi and Z.D.S. Al-Shamoosi, J. Mol. Liq., 243, 750 (2017); https://doi.org/10.1016/j.molliq.2017.08.081
M. Karikalan, M.G.R. Priya and P. Shanmugapandiyan, Int. J. Pharma BioSci., 7, 240 (2016).
G. Ngwa, Drug Deliv. Technol., 10, 56 (2010).
R. Singh and Z. Rehman, J. Pharm. Educ. Res., 3, 54 (2012).
S.B. Kanthale, S.S. Thonte and B.B. Supekar, Int. J. Pharm. Sci. Res., 10, 1625 (2019).
International Conference on the Harmonization, ICH Harmonized Tripartite Guideline, Stability Testing of New Drug Substances and Products Q1A (R2) (2003).
International Conference on the Harmonization, ICH Harmonized Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2 (R1) (2005).