HPLC–DAD method for investigating pantoprazole for its stress-dependent degradation by photolysis and oxidation

• Autorzy: Bratty Mohammad , Thangavel Neelaveni , Peraman Ramalingam , Kumar Vinod , Reddy Padmanabha , Nagappan Krishna Veni , Hazmi Hassan Al

Identyfikatory

DOI

10.1556/1326.2019.00709

• Języki publikacji: EN

Abstrakty

EN

A reversed-phased high-performance liquid chromatography–diode-array detection (HPLC–DAD) method has been developed for investigating the stress-dependent degradation of pantoprazole (PTZ) by a photolytic and oxidative mechanism. The developed method separated PTZ from its degradation products on a C18 column with a mobile phase consisted of methanol and water (60:40, v/v; pH 3.0) at a flow rate of 1 mL/min. The linear regression coefficient of 0.9995 was obtained for a concentration range from 5 to 25 μg/mL. The % relative standard deviation for repeatability and intermediate precision were below 0.5% and 1.5%, respectively, while the sensitivity of the method was demonstrated by a limit of detection value of 0.25 μg/mL. The stress sample analyses for PTZ results revealed the formation of a total of 18 degradation products, and out of them, 9 degradation products were common for both photolytic and oxidative degradations. Further, the oxidation by azobisisobutyronitrile produced the highest number of degradation products (11 impurities), 3 of which are more hydrophobic than PTZ. In photolytic degradation, 8 and 7 degradation products were observed with UV radiation and sunlight exposure, respectively. Furthermore, the degradation of pantoprazole sodium injection formulation was carried out under the same stress conditions, and it revealed the formation of 3 common impurities under both stress conditions, but other impurities were not detected in the formulations. Finally, 3 common impurities formed in formulations of PTZ injections, viz., sulfone, N-oxide, and N-oxide sulfone impurities, were identified by spike analyses.

Słowa kluczowe

EN

RP-HPLC; pantoprazole; photolytic; oxidative

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2020
• Tom: Vol. 32, no. 4
• Strony: 247--255
• Opis fizyczny: Bibliogr. 23 poz., rys.

Twórcy

autor

Bratty Mohammad

• Jazan University, Jazan, P.O. Box 114, KSA

autor

Thangavel Neelaveni

• Jazan University, Jazan, P.O. Box 114, KSA

autor

Peraman Ramalingam

• Raghavendra Institute of Pharmaceutical Education and Research Campus, Anantapuramu, Andhra Pradesh, India

autor

Kumar Vinod

• Raghavendra Institute of Pharmaceutical Education and Research – Autonomous, Anantapuramu, Andhra Pradesh, India

autor

Reddy Padmanabha

• Raghavendra Institute of Pharmaceutical Education and Research – Autonomous, Anantapuramu, Andhra Pradesh, India

autor

Nagappan Krishna Veni

• JSS College of Pharmacy, Ooty [A Constituent College – JSS Academy of Higher Education & Research], The Nilgiris, Tamil Nadu, India

autor

Hazmi Hassan Al

• Jazan University, Jazan, P.O. Box 114, KSA

Bibliografia

• [1] FDA Guidance for Industry , INDs for Phase II and III Studies – Chemistry, Manufacturing, and Controls Information, Food and Drug Administration, Available from: 2003.
• [2] International Conference on Harmonization , ICH Q2 Guidelines, Available from: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128204.pdf, 2003.
• [3] Reynolds, D. W.; Facchine, K. L.; Mullaney, J. F. Pharm. Technol. 2002, 26, 48.
• [4] Brummer H. Life Sci. Technol. Bull. 2011, 1, 1.
• [5] Gupta, K. R.; Chawla, R. B.; Wadodkar, S. G. Orbital: Electron. J. Chem. 2010, 2, 181.
• [6] Wahbi, A. M.; Abde Razak, O.; Gazy, A. A.; Mahgoub, A.; Moneeb, M. S. J. Pharm. Biomed. Anal. 2002, 30, 1133.
• [7] Syed, A.; Syeda, A. Indian J. Pharm. Sci. 2008, 70, 507.
• [8] Prasanna, R. B.; Kirankumar, R. N. Int. J. ChemTech Res. 2009, 1, 195.
• [9] Letica, J.; Markovic Zirojevic, S. J.; Nikolic, K.; Agbaba, D. J. AOAC Int. 2010, 93, 1121.
• [10] Ramakrishna, N. V. S.; Vishwottam, K. N.; Wishu, S.; Koteshwara, M. J. Chromatogr. B: Anal. Technol. Biomed. Life Sci. 2005, 822, 326.
• [11] Li, Y.; Ding, M. J.; Ma, J.; Wang, S.; Wu, X. L.; Xu, H. J.; Lu, Z. Y.; Zou, J. J.; Fan, H. W.; Zhou, X. M. Eur. J. Drug Metab. Pharmacokinet. 2011, 35, 147.
• [12] Dotsikas, Y.; Apostolou, C.; Soumelas, S.; Kolocouri, F.; Ziaka, A.; Kousoulos, C.; Loukas, Y. L. J. AOAC Int. 2010, 93, 1129.
• [13] Challa, B. R.; Boddu, B. R.; Awen, B. Z.; Chandu, B. R.; Bannoth, C. K.; Khagga, M.; Kanala, K.; Shaik, R. J. Chromatogr. B: Anal. Technol. Biomed. Life Sci. 2010, 878, 1499.
• [14] Patel, B. H.; Suhagia, B. N.; Patel, M. M.; Patel, J. R. J. AOAC Int. 2007, 90, 142.
• [15] Deepak Bageshwar, V.; Khanvilkar, V. K. J. Pharm. Anal. 2011, 1, 275.
• [16] Radi A. J. Pharm. Biomed. Anal. 2003, 33, 687.
• [17] Krishna, R. G.; Rajesh, B. C.; Sudhir, G. W. Orbital: Electron. J. Chem. 2010, 2, 209.
• [18] Reddy, G. M.; Bhaskar, B. V.; Reddy, P. P.; Ashok, S.; Sudhakar, P.; Babu, J. M.; Vyas, K.; Mukkanti, K. J. Pharm. Biomed. Anal. 2007, 45, 201.
• [19] Ronald F. D. ; Can. J. Hosp. Pharm. 2011, 64, 192.
• [20] Walker, S.; Iazzetta, J.; Law, S. Can. J. Hosp. Pharm. 2009, 62,135.
• [21] Walker, S. E.; Iazzetta, J.; Law, S. Can. J. Hosp. Pharm. 2005, 58, S34.
• [22] Carpenter, J. F.; McNulty, M. A.; Dusci, L. J.; Ilett, K. F. J. Pharm. Technol. 2006, 22, 95.
• [23] Johnson C. E . Am. J. Health-Syst. Pharm. 2005, 62, 2410.

Uwagi

PL

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