Stability-indicating high performance liquid chromatographic determination of bendamustine hydrochloride (an anti-cancer agent) as bulk drug and in pharmaceutical dosage form

Drug Invention Today

Volumn 4, Issue 12, 2012, Pages 629-634

  Mathrusri Annapurna, M ^a   Sai Pavan Kumar, B ^a   Raj Prakash, J ^a  

^a GITAM UNIVERSITY   (India)

Author keywords

Alkaline degradation; Bendamustine hydrochloride; ICH; RP HPLC; Stability indicating

Indexed keywords

ACETONITRILE; BENDAMUSTINE; BENDIT; PHOSPHORIC ACID; PURPLZ; UNCLASSIFIED DRUG; WATER;

ACCURACY; ACIDITY; ALKALINITY; ANALYTICAL PARAMETERS; ARTICLE; CONTROLLED STUDY; DRUG DEGRADATION; DRUG DETERMINATION; DRUG DOSAGE FORM COMPARISON; DRUG SELECTIVITY; DRUG STABILITY; DRUG STRUCTURE; FLOW RATE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; LIMIT OF DETECTION; LIMIT OF QUANTITATION; LINEAR SYSTEM; OXIDATION; REVERSED PHASE LIQUID CHROMATOGRAPHY; ROBUSTNESS; SENSITIVITY AND SPECIFICITY; TABLET; TEMPERATURE STRESS; VALIDATION STUDY;

EID: 84876250092     PISSN: 09757619     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (12)

1. Friedberg JW, Cohen P, Chen L, Robinson KS, Forero-Torres A, La Casce AS, et al. Bendamustine in patients with rituximab-refractory indolent and transformed non-Hodgkin's lymphoma: results from a phase II multicenter, single-agent study, J. Clin. Oncol. 26, 2008, 204- 210.
2. Lissitchkov T, Arnaudov G, Peytchev D, Merkle Kh. Phase-I/II study to evaluate dose limiting toxicity, maximum tolerated dose, and tolerability of Bendamustine HCl in pre-treated patients with Bchronic lymphocytic leukaemia (Binet stages B and C) requiring therapy. J. Cancer Research and Clin. Oncol. 132, 2006, 99-104.
3. Teichert J, Sohr R, Baumann F, Hennig L, Merkle K, Caca K, et al. Synthesis and characterization of some new phase II metabolites of the alkylator Bendamustine and their identification in human bile, urine, and plasma from patients with cholangiocarcinoma. Drug Metabolism and Disposition. 33, 2005, 984-992.
4. Matt Kalaycio. Clinical experience with Bendamustine: A new treatment for patients with chronic lymphocytic leukemia. Clin Leukemia 2, 2008, 223-229.
5. Teichert J, Baumann F, Chao Q, Franklin C, Bailey B, Hennig L. Characterization of two phase I metabolites of Bendamustine in human liver microsomes and in cancer patients treated with Bendamustine hydrochloride. Cancer Chemother. Pharmacol. 59, 2007, 759-770.
6. Rasschaert M, Schrijvers D, Van den Brande J, Dyck J, Bosmans J, Merkle K, et al. A phase I study of Bendamustine hydrochloride administered once every three weeks in patients with solid tumors. Brit. J. Cancer 96, 2007, 1692-1698.
7. Preiss R, Sohr R, Matthias M, Brockmann B, Huller H. The pharmacokinetics of Bendamustine (Cytostasane) in humans. Die Pharmazie, 40, 1985, 782-784.
8. Ivanka Pencheva, Anita Bogomilova, Neli Koseva, Danka Obreshkova, Kolio Troev. HPLC study on the stability of Bendamustine hydrochloride immobilized onto polyphosphoesters. J Pharm Biomed Anal, 48, 2008, 1143-1150.
9. Mathrusri Annapurna M, Venkatesh B, Anusha S and Neelima B. Stability-Indicating Liquid Chromatographic Method for the Determination of Bendamustine Hydrochloride in Parenterals, Res. J. Chem. Sci. 2(9), 2012, 72-78.
10. Mathrusri Annapurna M, Pavani S, Anusha S, Harika Mahanti and Venkatesh B. New analytical methods for the determination of Bendamustine hydrochloride - An anti-neoplastic drug. J. Chem. and Pharm. Res. 4, 2012, 1696-1701.
11. ICH Validation of analytical procedures: Text and methodology Q2(R1),International Conference on Harmonization, 2005.
12. ICH Stability Testing of New Drug Substances and Products Q1A (R2), International Conference on Harmonization, 2003.