title: Development and validation of a sensitive liquid chromatographic method for the analysis of a novel radioprotectant: ON 01210.Na.
abstract: ON 01210.Na is a chlorobenzylsulfone derivative with potential property to mitigate the effects of accidental or intentional exposure to life threatening levels of radiation. A simple and sensitive HPLC method was developed and validated for the assay of ON 01210.Na. The isocratic system used a mobile phase consisting of acetonitrile:0.1% trifluroacetic acid in water (60:40, v/v) at a flow rate of 1 ml/min. The method used a C-18 Gemini column (250 mm x 4.6 mm) with column effluents monitored at 254 nm. Forced degradation of the drug was achieved by autoclaving ON 01210.Na with 0.05 N HCl, 0.05 N NaOH or 1.5% (v/v) hydrogen peroxide. The assay validation parameters evaluated include specificity, linearity, precision, accuracy and sensitivity. The retention time of the drug and the other effluents were well within 7 min. Standard curves were linear over the concentration range of 10-500 microg/ml. The R.S.D. values for the within-day and day-to-day precision ranged from 0.4 to 2.5 and 2.2 to 4.4%, respectively. The R.S.D. for accuracy measurement ranged from 0.85 to 1.7%. The critical level, the detection level and the determination level for this assay were 2.86+/-0.67, 5.69+/-0.67 and 15.6+/-1.8 microg/ml, respectively. A simple, sensitive and stability indicating HPLC assay was developed and validated for the analysis of a novel radioprotectant. This method was used to evaluate the aqueous as well as solid-state stability of this drug during autoclaving.
authors.affiliation: Department of Pharmacy Sciences, Creighton University Medical Centre, Omaha, NE 68178, USA.
authors.forename: Parina P
authors.initials: PP
authors.lastname: Fernandes
authors.forename: Manoj
authors.initials: M
authors.lastname: Maniar
authors.forename: Alekha K
authors.initials: AK
authors.lastname: Dash
mesh_terms: D000097:Acetonitriles / Q000737:chemistry; D002853:Chromatography, Liquid / Q000295:instrumentation / Q000379:methods*; D004355:Drug Stability; D006851:Hydrochloric Acid / Q000494:pharmacology; D008698:Mesylates / Q000737:chemistry*; D011837:Radiation-Protective Agents / Q000032:analysis* / Q000737:chemistry; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012972:Sodium Hydroxide / Q000494:pharmacology; D013449:Sulfonamides / Q000032:analysis* / Q000737:chemistry; D014269:Trifluoroacetic Acid / Q000737:chemistry; D014867:Water / Q000737:chemistry
chemical_list: C520364:(E)-4-carboxystyryl-4-chlorobenzylsulfone, sodium salt; D000097:Acetonitriles; D008698:Mesylates; D011837:Radiation-Protective Agents; D013449:Sulfonamides; D014867:Water; D012972:Sodium Hydroxide; C035617:phenylmethanesulfonic acid; D014269:Trifluoroacetic Acid; D006851:Hydrochloric Acid; C032159:acetonitrile