title: Stability-indicating LC method for the estimation of bendamustine hydrochloride and its related impurities.
abstract: A novel, simple, sensitive and stability-indicating high-performance liquid chromatography method was developed and validated for the quantification of impurities (process related and degradants) and the assay determination of Bendamustine hydrochloride. A chromatographic separation of Bendamustine and its impurities was achieved with an Inertsil ODS-2 analytical column, 250 × 4.6 mm, 5 µm, using gradient elution with mobile phase A consisting of a mixture of water and trifluoroacetic acid (1000:1, v/v) and mobile phase B consisting of acetonitrile. The instrumental settings included a flow rate of 1.0 mL/min, column temperature of 27°C and a detector wavelength of 233 nm, using a photodiode array detector. The tailing factor for Bendamustine was 1.10. Bendamustine hydrochloride was exposed to thermal, photolytic, hydrolytic and oxidative stress conditions and the stressed samples were analyzed by the proposed method. Peak homogeneity data of Bendamustine were obtained by using a photodiode array detector in the stressed sample chromatograms, which demonstrated the specificity of the method for estimation in the presence of degradants. The developed method was validated for parameters such as precision, accuracy, linearity, limit of detection, limit of quantification, ruggedness and robustness. The stability tests were also performed on drug substances as per International Conference on Harmonization guidelines.
authors.affiliation: Dr. Reddy's Laboratories Ltd. Active Pharmaceutical Ingredients, IPDO, Bachupally, Hyderabad-500072, Andhra Pradesh, India Department of Chemistry, Osmania University, Hyderabad 500072, Andhra Pradesh, India kasas82003@yahoo.co.in.
authors.forename: Srinivasulu
authors.initials: S
authors.lastname: Kasa
authors.affiliation: Dr. Reddy's Laboratories Ltd. Active Pharmaceutical Ingredients, IPDO, Bachupally, Hyderabad-500072, Andhra Pradesh, India.
authors.forename: M
authors.initials: M
authors.lastname: Raja Sekhar Reddy
authors.affiliation: Dr. Reddy's Laboratories Ltd. Active Pharmaceutical Ingredients, IPDO, Bachupally, Hyderabad-500072, Andhra Pradesh, India.
authors.forename: Raja Sekhar
authors.initials: RS
authors.lastname: Kadaboina
authors.affiliation: Dr. Reddy's Laboratories Ltd. Active Pharmaceutical Ingredients, IPDO, Bachupally, Hyderabad-500072, Andhra Pradesh, India.
authors.forename: Veerender
authors.initials: V
authors.lastname: Murki
authors.affiliation: Department of Chemistry, Osmania University, Hyderabad 500072, Andhra Pradesh, India Mylan Laboratories Limited, Plot No.34 A, Anrich Industrial Estate, Bollaram, Jinnaram (Mandal), Medak Dist - 502 32, Andhra Pradesh, India.
authors.forename: Venkata Suryanarayana
authors.initials: VS
authors.lastname: Mulukutla
mesh_terms: D000069461:Bendamustine Hydrochloride; D002853:Chromatography, Liquid / Q000379:methods*; D004340:Drug Contamination; D004355:Drug Stability; D006863:Hydrogen-Ion Concentration; D016014:Linear Models; D009588:Nitrogen Mustard Compounds / Q000032:analysis* / Q000737:chemistry*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D053719:Tandem Mass Spectrometry / Q000379:methods*
chemical_list: D009588:Nitrogen Mustard Compounds; D000069461:Bendamustine Hydrochloride