Determination and stability testing method of chlorpheniramine maleate in the presence of tartrazine using HPLC
The single-component CPM tablet mostly used sodium tartrazine as the yellow coloring agent. Sodium tartrazine is soluble in solvents used to extract CPM from tablet and suspected interference CPM determination especially after forced degradation for stability indication testing of CPM tablets. This study aimed to develop a selective, accurate and precise method for determination and stability testing of chlorpheniramine maleate (CPM) in the presence of tartrazine in the tablet. A µBondapak® C18 column (3.9 x 300 mm, 10 µm) with diode array detector was used for separation. The mobile phase was a mixture of methanol and 0.2% triethylamine (90:10) with a flow rate of 2 mL/minutes. The validated HPLC method was used for CPM determination in tablet samples that had been forced degraded using dry heat at 105oC, UV radiation of 254 nm, hydrolysis with 1N NaOH, 1N HCl and oxidation using 5% H2O2. The HPLC chromatogram showed that CPM split into chlorpheniramine (CP) and maleic acid (MA). Resolution (Rs) among CP and the other analytes especially with the products resulting from the forced degradation by heat, UV radiation, HCl, and H2O2 were good. The CPM hydrolysis using NaOH caused the CP not completely separated from the degradation product due to tailing or overlapping peaks. The proposed HPLC method was valid for the determination of CPM in tablets containing tartrazine. Even though the stability-indicating method was inadequate especially for the result of the CPM hydrolysis process using NaOH.
Alagić-Džambić, L., Vehabović, M., Čekić, E., & Džambić, M. (2014). Development and validation of a HPLC method for chlorphenamine maleate related substances in multicomponents syrups and tablets. International Journal of Pharmacy Teaching & Practices, 5(3), 997–1001.
Ali, A., Ahmed, M., Mahmud, T., Qadir, M., Nadeem, K., & Saleem, A. (2016). Stability-indicating High-performance liquid chromatography method for simultaneous determination of aminophylline and chlorpheniramine maleate in pharmaceutical formulations. Indian Journal of Pharmaceutical Sciences, 77(5), 515. https://doi.org/10.4103/0250-474x.169042.
Ali, H., Shoaib, M. H., & Bushra, R. (2011). Formulation development of chlorpheniramine maleate tablet by direct compression. Jordan Journal of Pharmaceutical Sciences, 4(1), 1–8.
AOAC International. (2013). AOAC Official Methods of Analysis - Appendix K: Guidelines for Dietary Supplements and Botanicals, 32.
Blessy, M., Patel, R. D., Prajapati, P. N., & Agrawal, Y. K. (2014). Development of forced degradation and stability indicating studies of drugs - A review. Journal of Pharmaceutical Analysis, 4(3), 159–165. https://doi.org/10.1016/j.jpha.2013.09.003.
Chlorpheniramine Maleate. (2016a). In The United States Pharmacopeia 39/The National Formulary 34, Vol 2. Rockville, MD 20852: The United states Pharmacopoeial Convention.
Chlorpheniramine Maleate. (2016b). In British Pharmacopoeia 2016. London: The Stationary office.
Darwish, H. W., Metwally, F. H., & El Bayoumi, A. (2015a). Development of three methods for simultaneous quantitative determination of chlorpheniramine maleate and dexamethasone in the presence of parabens in oral liquids. Tropical Journal of Pharmaceutical Research, 14(1), 153–161. https://doi.org/10.4314/tjpr.v14i1.22.
Darwish, H. W., Metwally, F. H., & El Bayoumi, A. (2015b). Discrete wavelet transform-partial least squares versus derivative ratio spectrophotometry for simultaneous determination of chlorpheniramine maleate and dexamethasone in the presence of parabens in pharmaceutical dosage form. Tropical Journal of Pharmaceutical Research, 14(5), 859–867. https://doi.org/10.4314/tjpr.v14i5.17.
Karikalan, M., Priya, M. G., & Shanmugapandiyan, P. (2016). Stabilitty indicating method development and validation for the quantification of chlorphenamine maleate related subtances using hplc technique. International Journal of Pharma and Bio Sciences, 7(4), 240–244. https://doi.org/10.22376/ijpbs.2016.7.4.p240-244.
Klorfeniramin Maleat. (2014). In Farmakope Indonesia (5th ed.). Jakarta: DepKes RI.
Kommana, R., & Basappa, P. (2013). Validated stability indicating RP-HPLC method for simultaneous estimation of codeine phosphate and chlorpheniramine maleate from their combined liquid dosage form. Chromatography Research International, 2013, 1–7. https://doi.org/10.1155/2013/404727.
Raghu, M. S., Basavaiah, K., Ramesh, P. J., Abdulrahman, S. A. M., & Vinay, K. B. (2012). Development and validation of a UV-spectrophotometric method for the determination of pheniramine maleate and its stability studies. Journal of Applied Spectroscopy, 79(1), 131–138. https://doi.org/10.1007/s10812-012-9574-6.
Saleh, T. A. (2011). Sensing of chlorpheniramine in pharmaceutical applications by sequential injector coupled with potentiometer. Journal of Pharmaceutical Analysis, 1(4), 246–250. https://doi.org/10.1016/j.jpha.2011.09.002.
Srinivasan, J. R., & Kawamura, Y. (2016). 82nd JECFA - Chemical and Technical Assessment (CTA), 2016 © FAO 2016 ROSEMARY EXTRACT Chemical and Technical Assessment (CTA), (5957), 1–7.
USP 39/NF 34. (2016). Chlorpheniramine Maleate Tablets. In United State of Pharmacopoeia 39/National Formulary 34. Rockville, MD: The United state Pharmacopoeial Convention.
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