Development and validation of a sensitive liquid chromatographic method for the analysis of a novel radioprotectant

ON 01210.Na

Parina P. Fernandes, Manoj Maniar, Alekha K. Dash

Research output: Contribution to journalArticle

5 Citations (Scopus)

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 × 4.6 mm) with column effluents monitored at 254 nm. Forced degradation of the drug was achieved by autoclaving ON 01210.Na with 0.05N HCl, 0.05N 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 μg/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 μg/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.

Original languageEnglish
Pages (from-to)1796-1803
Number of pages8
JournalJournal of Pharmaceutical and Biomedical Analysis
Volume43
Issue number5
DOIs
StatePublished - Apr 11 2007

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Liquid Chromatography
Assays
Liquids
High Pressure Liquid Chromatography
Drug Stability
Effluents
Pharmaceutical Preparations
Hydrogen Peroxide
Radiation
Acids
Water
Flow rate
Derivatives
Degradation
acetonitrile

All Science Journal Classification (ASJC) codes

  • Analytical Chemistry
  • Pharmaceutical Science

Cite this

Development and validation of a sensitive liquid chromatographic method for the analysis of a novel radioprotectant : ON 01210.Na. / Fernandes, Parina P.; Maniar, Manoj; Dash, Alekha K.

In: Journal of Pharmaceutical and Biomedical Analysis, Vol. 43, No. 5, 11.04.2007, p. 1796-1803.

Research output: Contribution to journalArticle

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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 × 4.6 mm) with column effluents monitored at 254 nm. Forced degradation of the drug was achieved by autoclaving ON 01210.Na with 0.05N HCl, 0.05N 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 μg/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 μg/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.",
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