Abstract
References
- [1] Remington, The Science and Practice of Pharmacy, twenty second ed., Pharmaceutical Press, London, ENG, UK, 2013.
- [2] USP 39/NF 34 Chlorpheniramine maleate tablets. In: United State of Pharmacopoeia 39/National Formulary 34. (Eds). The United state Pharmacopoeial Convention, Rockville, 2014, pp. 312–316.
- [3] Tartrazine, 82nd JECFA—Chemical and Technical Assessment (CTA) 2016. JECFA-Chemical Tech Assess. http://www.fao.org/3/a-br567e.pdf (accessed on 17 October 2018).
- [4] Farmakope Indonesia V, Klorfeniramin Maleat, DepKes RI, Jakarta, JKT, ID, 2014.
- [5] British Pharmacopoeia, Chlorpheniramine Maleate, The Stationary office, London, ENG, UK, 2016.
- [6] Acheampong A, Gyasi WO, Darko G, Apau J, Addai-Arhin S. Validated RP-HPLC method for simultaneous determination and quantification of chlorpheniramine maleate, paracetamol and caffeine in tablet formulation. Springerplus. 2016; 5: 625. [CrossRef]
- [7] Darwish HW, Metwally FH, El Bayoumi A. Development of three methods for simultaneous quantitative determination of chlorpheniramine maleate and dexamethasone in the presence of parabens in oral liquids. Trop J Pharm Res. 2015; 14(1): 153–161. [CrossRef]
- [8] Darwish HW, Metwally FH, El Bayoumi A. 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. Trop J Pharm Res. 2015; 14(5): 859–867. [CrossRef]
- [9] Kaura AK, Gupta V, Kaura M, Roy GS, Bansal P. Spectrophotometric determination of Chlorpheniramine Maleate and Phenylpropanolamine Hydrochloride by “two wavelengths method”. J Pharm Res. 2013; 7(5): 404–408. [CrossRef]
- [10] Antakli S, Nejem L, Katran S. Simultaneous determination of tartrazine and brilliant blue in foodstuffs by spectrophotometric method. Int J Pharm Pharm Sci. 2015; 7(6): 214–218.
- [11] AOAC International, Official Methods of Analysis of AOAC International, AOAC International, Rockville, MD, US, 2012.
- [12] Yuwono M, Indrayanto G. Validation of chromatographic methods of analysis. In: Brittain Harry G. (Eds). Profiles of Drug Substances,Excipients and Related Methodology. Elsevier BV, Netherlands, 2005, pp. 243–259.
- [13] Niazi SK. Handbook of Pharmaceutical Manufacturing Formulation: Compressed Solid Formulations, second ed., Informa Healthcare, New York, NY, US, 2004.
Comparison of UV-spectrophotometry and high- performance liquid chromatography for determination of chlorpheniramine maleate in tablet in the presence of tartrazine
Abstract
The presence of tartrazine, yellow coloring agent, suspected to interfere with the CPM determination in CPM tablets using direct spectrophotometry or high performance liquid chromatography. Overlap spectra of tartrazine and CPM at an analytical wavelength and peak tailing were the main problem occurs in CPM tablets analysis. The aim of this study was to develop a derivative UV spectrophotometry and a modified HPLC to overcome the problem in CPM tablet analysis. Both validated methods were applied for the determination of CPM content in three registered CPM tablets. As a result, the first derivative spectrophotometry method obtained the δA/δλ of tartrazine in matrix tablet was nearly zero at the wavelength of 232 nm and did not interfere with the δA/δλ of CPM. The selective mobile phase for separation of CPM from tartrazine using HPLC method was a mixture of phosphate buffer pH 4 and methanol (60:40 v/v) with a flow rate of 1 ml/min. The CPM separated from tartrazine and other peaks in sample(s) with Rs of >1.5 The linearity, accuracy, and precision of these two methods fulfilled the reference requirement. No significant difference observed between the CPM content in artificial tablets when analyzed using first-derivative spectrophotometry and HPLC method. The concentration of CPM in one registered tablet that had been assayed using spectrophotometry, HPLC and the standard method was not significantly different. As a conclusion first-derivative spectrophotometry and HPLC method were valid for the determination of CPM in a tablet containing tartrazine. However, the first-derivative spectrophotometry method was more efficient than HPLC.
References
- [1] Remington, The Science and Practice of Pharmacy, twenty second ed., Pharmaceutical Press, London, ENG, UK, 2013.
- [2] USP 39/NF 34 Chlorpheniramine maleate tablets. In: United State of Pharmacopoeia 39/National Formulary 34. (Eds). The United state Pharmacopoeial Convention, Rockville, 2014, pp. 312–316.
- [3] Tartrazine, 82nd JECFA—Chemical and Technical Assessment (CTA) 2016. JECFA-Chemical Tech Assess. http://www.fao.org/3/a-br567e.pdf (accessed on 17 October 2018).
- [4] Farmakope Indonesia V, Klorfeniramin Maleat, DepKes RI, Jakarta, JKT, ID, 2014.
- [5] British Pharmacopoeia, Chlorpheniramine Maleate, The Stationary office, London, ENG, UK, 2016.
- [6] Acheampong A, Gyasi WO, Darko G, Apau J, Addai-Arhin S. Validated RP-HPLC method for simultaneous determination and quantification of chlorpheniramine maleate, paracetamol and caffeine in tablet formulation. Springerplus. 2016; 5: 625. [CrossRef]
- [7] Darwish HW, Metwally FH, El Bayoumi A. Development of three methods for simultaneous quantitative determination of chlorpheniramine maleate and dexamethasone in the presence of parabens in oral liquids. Trop J Pharm Res. 2015; 14(1): 153–161. [CrossRef]
- [8] Darwish HW, Metwally FH, El Bayoumi A. 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. Trop J Pharm Res. 2015; 14(5): 859–867. [CrossRef]
- [9] Kaura AK, Gupta V, Kaura M, Roy GS, Bansal P. Spectrophotometric determination of Chlorpheniramine Maleate and Phenylpropanolamine Hydrochloride by “two wavelengths method”. J Pharm Res. 2013; 7(5): 404–408. [CrossRef]
- [10] Antakli S, Nejem L, Katran S. Simultaneous determination of tartrazine and brilliant blue in foodstuffs by spectrophotometric method. Int J Pharm Pharm Sci. 2015; 7(6): 214–218.
- [11] AOAC International, Official Methods of Analysis of AOAC International, AOAC International, Rockville, MD, US, 2012.
- [12] Yuwono M, Indrayanto G. Validation of chromatographic methods of analysis. In: Brittain Harry G. (Eds). Profiles of Drug Substances,Excipients and Related Methodology. Elsevier BV, Netherlands, 2005, pp. 243–259.
- [13] Niazi SK. Handbook of Pharmaceutical Manufacturing Formulation: Compressed Solid Formulations, second ed., Informa Healthcare, New York, NY, US, 2004.
Details
| Primary Language | English |
|---|---|
| Subjects | Pharmaceutical Chemistry |
| Journal Section | Articles |
| Authors | |
| Publication Date | June 27, 2025 |
| Published in Issue | Year 2020 Volume: 24 Issue: 2 |