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Improved Analytical Method for Dicholorobenzaldehyde Impurity Detection in Lozenges by Convergence Chromatography
Lozenges are the commonly used throat relieving pharmaceutical product that contains DBA and AMC as their active pharmaceutical ingredients. Reports have shown that during the longer storage conditions DBA converts to toxic 2, 4, dichlorobenzaldehyde (DCBZ). Present study reports the development of novel method for detection of DCBZ with UPC2 (Ultra performance convergence chromatography) instrument, that utilize the potential supercritical fluid chromatography, which is sustainable, reduced cost and green technology reducing the use of organic solvent. In this simple and robust method to detect DCBZ, runtime reduced to 2 minutes as compared to 10 min by Gas Chromatography with higher precision. By utilizing conventional method of Gas Chromatography, 2, 4, dichlorobenzaldehyde is detectable but with very low response and interference with other ingredients use in Lozenges. Method has facilitated faster detection and more sensitivity for DCBZ detection. The improved method provides less flow rate during the process, making it highly cost-effective. Use of non-polar solvents, high to low gradient is some of the advantages of the improved method of present investigation when compared to traditional method. The improved process of present invention proves to be 27 times more cost-effective.
Keywords
2,4 - Dichlorobenzaldehyde, Di Benzyl Alcohol, Gas Chromatography, Lozenges Ultra Performance Convergence Chromatography.
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- Ramond CR, Astrazenca. Formulating fortunes the tale of medicated Lozenges. Drug Discovery Today. 2002; 7(5):286–7. crossref
- Umashankar MS, Dinesh SR, Rinin R, Lakshmi KS, Damodharan N. Chewable Lozenge formulation-A Review. Int. J. Pharmacy. 2016; 7(4):9–16. crossref
- European Medicines Agency. EMA/CHMP/ICH/353369/2013. ICH guideline Q3D on elemental impurities; 2016, p. 1–84.
- Rizk M, Ibrahim F, Hefnawy M, Nasr JJ. Micellar liquid chromatographic analysis of benzyl alcohol and benzaldehyde in injectable formulations. Acta Pharm. 2007; 57:231–9. crossref PMid:17507319
- Hong JY, Park NH, Yoo KH, Hong J. Comprehensive profiling and quantification of Sudan III dyes by gas chromatography/ mass spectrometery. J Chromato. 2013;1297:186–95. crossref PMid:23726074
- Dhir NK, Chakraborty D, Kaur V. Green analytical technique for drug quantification. Patent No. 4299/DEL/2015. 2015.
- Wang LL, Zhang Y, Sun X, Chen S. Simultaneous quantitative analysis of main components in linderae reflexae radix with single one marker. J Liq Chromatogr Relat Technol. 2016; 39(8):422–7. crossref PMid:27366022 PMCid:PMC4917913
- Liu DQ, Sun M, Wu L. Eliminating pharmaceutical impurities: Recent advances in detection techniques. Curr Opin Drug Discov Devel. 2010; 13(6):748–57. PMid:21061235
- Oxford JS, Lambkin R, Gibb I, Balasingam S, Chan C, Catchpole A. A throat lozenge containing amyl meta cresol and dichlorobenzyl alcohol has a direct virucidal effect on respiratory syncytial virus influenza A and SARSCoV. Antiviral Chem Chemother. 2005; 16(2):129–34. crossref PMid:15889535
- Official Report in Pharmacopial Monograph. AMC in BP-2015. (I) 1-178.
- Official Report in Pharmacopial Monograph. DBA in 2, 4 Dichlorobenzyl alcohol- EU Phur -2014 8.1, 3745.
- Zhou Q, Gao B, Zhang XXY, Shi H, Yu LL. Chemical profiling of triacylglycerols and diacylglycerols in cow milk fat by ultra-performance convergence chromatography combined with a quadrupole time-of-flight mass spectrometry. Food Chem. 2014; 143:199–204. crossref PMid:24054231
- White CM. 1988. Modern Supercritical Fluid Chromatography, Huthig, Heidelberg (Ed.).
- Poon J, Katsifis A, Fulham M. An Alternate HPLC Method for the Analysis of Tetrabutylammonium Hydroxide in [18F] Fluorodeoxythymidine (FLT). J Liq Chromatogr. Relat Technol; 2017. dx.doi.org/10.1080/10826076.2017.1343733. crossref
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