Analysis of Paclitaxel in Pharmaceutical Injection by Ultra Performance Convergence Chromatography

Abstract:

A simple and sensitive ultra-performance convergence chromatography system coupled with a diode array detector for analysis of paclitaxel, 10-deacetyl-7-epipaclitaxel and cephalomannine in paclitaxel injection was developed. The analyses were carried out on a Waters Acquity UPC² BEH 2-EP using the mobile phase of mixture of supercritical CO₂ and methanol with a linear gradient elution from 92:8 to 82:18 at 50 °C. The method offers good linearity, higher resolution, and good repeatability. LOD and LOQ were 0.45 and 1.32 ng, respectively.

• Periodical: Advanced Materials Research (Volumes 989-994)
• Pages: 1060-1063
• DOI: https://doi.org/10.4028/www.scientific.net/AMR.989-994.1060
• Online since: July 2014
• Authors: Xiao Gong, Xiao Bing Huang, Yong Hua Wei, Ning Li Qi, Li Jing Lin*, Yang Yang Liu
• Keywords: Diode Array Detector, Paclitaxel, Ultra-Performance Convergence Chromatography

References

[1] Wani MC, Taylor HL, Wall ME, Coggon P, et al. Plant antitumor agents. VI. Isolation and structure of taxol, a novel antileukemic and antitumor agent from Taxus brevifolia [J]. Journal of the American Chemical Society, 1971, 93(9): 2325-2327.

DOI: 10.1021/ja00738a045

[2] Bharadwaj R, Yu HT. The spindle checkpoint, aneuploidy, and cancer [J]. Oncogene, 2004, 23(11): 2016-(2027).

DOI: 10.1038/sj.onc.1207374

[3] Jordan MA, Wilson L. Microtubules as a target for anticancer drugs [J]. Nature Reviews Cancer, 2004, 4(4): 253-265.

DOI: 10.1038/nrc1317

[4] Ganguly A, Yang HL, Cabral F. Paclitaxel-dependent cell lines reveal a novel drug activity [J]. Molecular Cancer Therapeutics, 2010, 9(11): 2914-2923.

DOI: 10.1158/1535-7163.mct-10-0552

[5] Hempel G, Lehmkuhl D, Krümpelmann S, Blaschke G, et al. Determination of paclitaxel in biological fluids by micellar electrokinetic chromatography [J]. Journal of Chromatography A, 1996, 745(1-2): 173-179.

DOI: 10.1016/0021-9673(96)00351-2

[6] Kim SC, Yu J, Lee JW, Park ES, et al. Sensitive HPLC method for quantitation of paclitaxel (Genexol®) in biological samples with application to preclinical pharmacokinetics and biodistribution [J]. Journal of Pharmaceutical and Biomedical Analysis, 2005, 39(1-2): 170-176.

DOI: 10.1016/j.jpba.2005.02.023

[7] Sun P, Wang X, Alquier L, Maryanoff CA. Determination of relative response factors of impurities in paclitaxel with high performance liquid chromatography equipped with ultraviolet and charged aerosol detectors [J]. Journal of Chromatography A, 2008, 1177(1): 87-91.

DOI: 10.1016/j.chroma.2007.11.035

[8] Zhang SQ, Chen GH. Determination of paclitaxel in human plasma by UPLC-MS-MS [J]. Journal of Chromatographic Science, 2008, 46(3): 220-224.

DOI: 10.1093/chromsci/46.3.220

[9] Heaton DM, Bartle KD, Rayner CM, Clifford AA. Application of supercritical fluid extraction and supercritical fluid chromatography to the production of taxanes as anti-cancer drugs [J]. Hrc-Journal of High Resolution Chromatography, 1993, 16(11): 666-670.

DOI: 10.1002/jhrc.1240161109

[10] Zhou Q, Gao BY, Zhang X, Xu YW, et al. Chemical profiling of triacylglycerols and diacylglycerols in cow milk fat by ultra-performance convergence chromatography combined with a quadrupole time-of-flight mass spectrometry [J]. Food Chemistry, 2014, 143(0): 199-204.

DOI: 10.1016/j.foodchem.2013.07.114

[11] United States Pharmacopeial Convention. Paclitaxel and paclitaxel injection [M]. USP35-NF30. 35th ed., New York, (2012).