Identification, characterization and quantification of a new impurity in deferasirox active pharmaceutical ingredient by LC-ESI-QT/MS/MS

Journal of Pharmaceutical and Biomedical Analysis

Volumn 63, Issue , 2012, Pages 112-119

  Thomas, Saji ^a   Chandra Joshi, Subhash ^a   Vir, Dharam ^a   Agarwal, Ashutosh ^a   Rao, Raghavendra Desai ^b   Sridhar, I ^b   Xavier, Cijo M ^b   Mathela, Chandra S ^c  

^a Jubilant Life Sciences Ltd   (India)

^b Analytical Research Department   (India)

^c KUMAUN UNIVERSITY   (India)

Author keywords

Deferasirox; Impurity; LC MS MS; NMR; Validation

Indexed keywords

BENZOIC ACID DERIVATIVE; DEFERASIROX; SALICYLAMIDE; SALICYLIC ACID;

ACCURACY; ARTICLE; CHEMICAL STRUCTURE; CONTROLLED STUDY; DRUG DEGRADATION; DRUG IMPURITY; DRUG STABILITY; DRUG SYNTHESIS; ELECTROSPRAY; INFRARED SPECTROSCOPY; LIMIT OF DETECTION; LIQUID CHROMATOGRAPHY; MASS FRAGMENTOGRAPHY; NONHUMAN; NUCLEAR MAGNETIC RESONANCE; PHYSICAL CHEMISTRY; PRIORITY JOURNAL; TANDEM MASS SPECTROMETRY;

BENZOATES; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CHROMATOGRAPHY, LIQUID; DRUG CONTAMINATION; GUIDELINES AS TOPIC; IRON CHELATING AGENTS; ISOMERISM; LIMIT OF DETECTION; MAGNETIC RESONANCE SPECTROSCOPY; MOLECULAR STRUCTURE; SPECTROMETRY, MASS, ELECTROSPRAY IONIZATION; SPECTROSCOPY, FOURIER TRANSFORM INFRARED; TANDEM MASS SPECTROMETRY; TECHNOLOGY, PHARMACEUTICAL; TRIAZOLES;

EID: 84858078959     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2012.01.024     Document Type: Article

References (22)

1. Martindale - The complete drug reference 2009, 471-477. Royal Pharmaceutical Society of Great Britain. thirty sixth ed. J.E.F. Reynolds (Ed.).
2. M. Valenvic, xPharm: The comprehensive pharmacology reference, 2008, 1-4.
3. Hider R.C. Charge states of deferasirox-ferric iron complexes. Am. J. Kidney Dis. 2010, 55:614-615.
4. Nick H. Deferasirox preclinical overview. Semin. Hematol. 2007, 44:12-15.
5. Cappellini M.D. Long-term efficacy and safety of deferasirox. Blood Rev. 2008, 22:35-41.
6. Chauzit E., Bouchet S., Mahon F.X., Moore N., Titier K., Molimard M. A method to measure deferasirox in plasma using HPLC coupled with MS/MS detection and its potential application. Ther. Drug Monit. 2010, 32:476-481.
7. Skerjane A., Wang J., Maren K., Rojkajer L. Investigation of the pharmacokinetic interactions of deferasirox, once daily oral iron chelator, wih midazolam, rifampin and repaglinide in healthy volunteers. J. Clin. Pharmacol. 2010, 50:205-213.
8. Bruin G.J.M., Faller T., Wiegand H., Schweitzer A., Schneider H.N.J., Boernsen K.O., Waldmeier F. Pharmacokinetics, distribution, metabolism, and excretion of deferasirox and its iron complex in rat. Drug Metab. Dispos. 2008, 36:2523-2538.
9. Raja R.K., Surendranath K.V., Radhakrishnan P., Satish J., Satyanarayana P.V.V. A stability indicating LC method for deferasirox in bulk drugs and pharmaceutical dosage forms. Chromatographia 2010, 72:441-446.
10. Chakravarthy V.K., Sankar D.G. LC determination of deferasirox in pharmaceutical formulation. J. Global Treat. Pharm. Sci. 2010, 1:42-52.
11. S.N. Reddy, E. Sajja, V. Reddy, S. Govindan, MSN Laboratories Limited, process for the preparation of 4-[3,5-bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl)-benzoic acid and its amine salts, World intellectual property organization, WO 2011/021218 A2, 2011.
12. ICH Guidelines, Q3A (R2), Impurities in new drug substances, October 25, 2006.
13. Sheldon E.M., Downar J.B. Development and validation of a single robust HPLC method for the characterization of a pharmaceutical starting material and impurities from three suppliers using three separate synthetic routes. J. Pharm. Biomed. Anal. 2000, 23:561-572.
14. Sheldon E.M. Development of a LC-MS complete heart-cut approach for the characterization of a pharmaceutical compounds using standard instrumentation. J. Pharm. Biomed. Anal. 2003, 31:1153-1166.
15. Bartos D., Gorog S. Recent advances in the impurity profiling of drugs. Curr. Pharm. Anal. 2008, 4:215-230.
16. Rao R.N., Nagaraju V. An overview of the recent trends in development of HPLC methods for the determination of impurities in drugs. J. Pharm. Biomed. Anal. 2003, 33:335-377.
17. Determination of Impurities in Drugs 1999, Elsevier Sciences, Amsterdam. S. Gorog (Ed.).
18. Ahuja S. Impurities Evaluation in Pharmaceuticals 1998, Marcel Dekker, New York.
19. Husain S., Rao R.N. Monitoring of process impurities in drugs. Advanced Chromatographic and Electromigration Methods in Biosciences 1998, 834-888. Elsevier Sciences, Amsterdam. Z. Dev1, I. Miksik, F. Taglirao, E. Tesarova (Eds.).
20. International Conference on Harmonization (ICH) Guidelines Q2 (R1), validation of analytical procedures: test and methodology, November, 2005.
21. R. Lattmann, P. Acklin, A.G. Novartis, Substituted 3,5-diphenyl-1,2,4-triazoles and their use as pharmaceutical metal chelators, World intellectual property organization, WO 97/49395, 1997.
22. International Conference on Harmonization (ICH) Guidelines, Q1B, photo stability testing of new drug substances and products.