A reliable HPLC-DAD method for simultaneous determination of related substances in TBI-166 active pharmaceutical ingredient

• Autorzy: Zhang Tingting , Yin Wanting , Jin Bo , Li Tong , Ma Chen

Identyfikatory

DOI

10.1556/1326.2019.00517

• Języki publikacji: EN

Abstrakty

EN

A sensitive, stability-indicating reversed-phase high-performance liquid chromatography with diode array detection (HPLC–DAD) method has been developed for the determination of TBI-166 and its 10 kinds of related impurities. Chromatographic separation was achieved on a Kromasil ODS column (250 mm × 4.6 mm, 5 μm), with a gradient elution of the mobile phase system consisting of acetonitrile and 1% ammonium formate solution (with 0.2% formic acid). The flow rate was 1.0 mL/min, and the detection wavelength was set at 251 nm. The method was validated according to the International Conference on Harmonization (ICH) guidelines with respect to selectivity, linearity, limits, accuracy, precision, and robustness. The calibration curves were linear from LOQ to 150% of the specification limit of impurity with correlation coefficients not less than 0.999. The limits of quantitation were between 0.123 and 0.257 μg/mL. Accuracy for the related substances was estimated by the recovery ranged from 94.6% to 111.2%. The method was proved to be reliable for the determination of related substances in TBI-166 bulk drug, which is essential and important in the quality control.

Słowa kluczowe

EN

TBI-166; HPLC-DAD; related substances; simultaneous determination; validation

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2020
• Tom: Vol. 32, no. 2
• Strony: 80--85
• Opis fizyczny: Bibliogr. 19 poz., rys., tab.

Twórcy

autor

Zhang Tingting

• Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, China

autor

Yin Wanting

• Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, China

autor

Jin Bo

• Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, China

autor

Li Tong

• Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, China

autor

Ma Chen

• Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, China

Bibliografia

• [1.] World Health Organization Global tuberculosis report 2018 World Health Organization, Geneva, Switzerland, 2018.
• [2.] Gandhi, N. R.; Nunn, P.; Dheda, K.; Schaaf, H.S.; Zigno, M.; Zignol, M.; Soolingen, D. V.; Jensen, P.; Bayona, J. The Lancet 2010, 375, 1830–1843.
• [3.] Palmer, B. D.; Thompson, A. M.; Sutherland, H. S.; Thompson, A. M.; Blaser, A.; Anderson, R. F.; Shinde, S. S.; Franzblau, S. G.; Ma, Z. K.; Denny, A. W.; Palmer, B. D. J. Med. Chem. 2010, 53, 282–294.
• [4.] Lu, Y.; Zheng, M. Q.; Wang, B.; Fu, L.; Zhao, W. J.; Li, P.; Xu, J.; Zhu, H.; Jin, H. X.; Yin, D. L.; Huang, H. H.; Upton, A. M.; Ma, Z. K. Antimicrob. Agents. Ch. 2011, 55, 5185–5193.
• [5.] Garrelts J. C. DICP 1991, 25, 525–531.
• [6.] Armand, V. D.; Maug, A. K. J.; Salim, M. A. H.; Das, P. K.; Sarker, M. R.; Daru, P.; Rieder, H. L. Am. J. Respir. Crit. Care Med. 2010, 182, 684–692.
• [7.] Xu, H. B.; Jiang, R. H.; Xiao, H. P. Clin. Microbiolv. Infec. 2012, 18, 1104–1110.
• [8.] Kasim, N. A.; Whitehouse, M.; Ramachandran, C.; Bermejo, M.; Lennernäs, H.; Hussain, A. S.; Junginger, H. E.; Stavchansky, S. A.; Midha, K. K. Mol. Pharmaceutics 2004, 1, 85–96.
• [9.] O’Connor, R.; O’Sullivan, J. F.; O’Kennedy, R. Drug. Metab. Rev. 1995, 27, 591–614.
• [10.] Kamal, A.; Hari, B. A.; Venkata, R. A.; Sinha, R.; Yadav, J. S.; Arora, S. K. Bioorg. Med. Chem. Lett. 2005, 15, 1923–1926.
• [11.] Zhang, D.; Lu, Y.; Liu, K.; Liu, B.; Wang, J.; Zhang, G.; Zhang, H.; Liu, Y.; Wang, B.; Zheng, M.; Fu, L.; Hou, Y.; Gong, N.; Lv, Y.; Li, C.; Cooper, C. B.; Upton, A. M.; Yin, D.; Ma, Z.; Huang, H. J. Med. Chem. 2012, 55, 8409–8417.
• [12.] Giovanna, P.; Martina, C.; Sara, C.; Mariangela, B. Eur. J. Med. Chem. 2014, 86, 335–351.
• [13.] Diana, Q.; Gayathri, N.; Richard, P.; James, A.T. Int. J. Infect. Dis. 2017, 56, 212–220.
• [14.] Li, D.; Sheng, L.; Liu, X.; Yang, S.; Liu, Z. H.; Li, Y. Chromatographia 2014, 77, 1697–1703.
• [15.] Liu, K.; Cooper, C. B.; Huang, H. H.; Li, C.; Liu, B. N.; Liu, Y.; Ma, Z. K.; Wang, J. B.; Yin, D. L.; Zhang, D. F.; Zhang, G.; Zhang, H. (New York, NY, US). Riminophenazines with 2-(heteroaryl) amino substituents and their anti-microbial activity. US Patent 8,716,292, May 06, 2014.
• [16.] Working Group for New TB Drugs Home Page. https://www.newtbdrugs.org/pipeline/clinical (accessed Jan 30, 2019).
• [17.] ICH Quality Q2 (R1), Validation of Analytical Procedures: Text and Methodology. http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html (accessed Dec. 2016).
• [18.] ICH Quality Guideline Q3A (R2), Impurities in new drug substance. http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html (accessed Dec. 2016).
• [19.] ICH Quality Guideline Q1A (R2), Stability testing of new drug substances and products. http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html (accessed Dec. 2016).

Uwagi

PL

Opracowanie rekordu ze środków MNiSW, umowa Nr 461252 w ramach programu "Społeczna odpowiedzialność nauki" - moduł: Popularyzacja nauki i promocja sportu (2020).