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Dynamic and Rapid Isocratic Greener Analytical Method for Estimation of Chlorocresol along with Azole Compounds in Ointment
Corresponding Author(s) : V. Kaur
Asian Journal of Chemistry,
Vol. 30 No. 1 (2018): Vol 30 Issue 1
Abstract
The present work describes greener analytical method for the estimation of chlorocresol along with azole compounds, which are used in the manufacturing of derma products. Method is optimized and validated for chlorocresol and miconazole nitrate, clotrimazole taken for identification. Dynamic separation and identification is achieved between 0.69 to 3 min by UPLC method. The UPLC method was validated using an UPLC (BEH RP C18) column with a particle size of 1.7 μ (50 mm × 2.1 mm) and methanol-buffer (60:40, v/v) as mobile phase by setting the flow rate of 0.4 mL/min with isocratic elution. Degradation pathway was optimized and evaluated through PDA and unspecified degradation product from chlorocresol was predicted by Waters Acquity UPLC with Xevo TQD triple quad mass spectrometer from Waters. The UPLC method is shortest time consuming run, suitable for quantifications within good manufacturing practices of the pharma industry and the method is validated according to ICH guidelines.
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- ICH Harmonized Tripartite Guideline, Validation of Analytical Procedures: Methodology (1996).
- A. Abou-elkheir, H.M. Saleh, M. Magda, B.S. Ghareeb and M.S. Mohram, Indo-Am. J. Pharm. Sci., 5, 641 (2015).
References
N.J. Dhir and S.K. Yadav, J. Indian Chem. Soc., 89, 1665 (2012).
N. Dhir, D. Chakraborty and V. Kaur, Patent filing number: 4299/DEL/2015.
S.E. Johnston, N.L. Gill, Y.C. Wei, R. Markovich and A.M. Rustum, J. Chromatogr. Sci., 48, 733 (2010); https://doi.org/10.1093/chromsci/48.9.733.
N. O’Connor, M. Geary, M. Wharton and P. Sweetman, J. Chromatogr. Sci., 50, 199 (2012); https://doi.org/10.1093/chromsci/bmr047.
European Pharmacopeia, version 8, vol. 2 (2015).
British Pharmacopeia, version 8, vol. 1, p. 519 (2015).
P.J. Dunn,A. Wells and M.T. Williams, Green Chemistry in the Pharmaceutical Industry, Wiley-VCH Verlag GmbH & Co (2010).
p-Chloro-m-cresol [MAK Value Documentation, 1991]. The MAK Collection for Occupational Health and Safety, 272 (2012).
A.A. Al-Badr, Profiles Drug Subst. Excip. Relat. Methodol., 32, 3 (2005); https://doi.org/10.1016/S0099-5428(05)32007-7.
S. Kadavakollu, C. Stailey, C.S. Kunapareddy and S. White, Med. Chem. (Los Angeles), 4, 722 (2014); https://doi.org/10.4172/2161-0444.1000219.
ICH Harmonized Tripartite Guideline, Validation of Analytical Procedures: Methodology (1996).
A. Abou-elkheir, H.M. Saleh, M. Magda, B.S. Ghareeb and M.S. Mohram, Indo-Am. J. Pharm. Sci., 5, 641 (2015).