Validation of an Analytical Method for assay of Magnesium Valproate by Gas Chromatography

نویسندگان

  • M. A. Ambasana
  • H. O. Kaila
  • R. S. Thakkar
  • H. T. Saravaia
  • A. K. Shah
چکیده

A simple, precise, and accurate stability indicating gas chromatographic method has been developed and validated for assay of Magnesium Valproate. The Chromatographic system used to perform development and validation of this assay method consisted of Shimadzu 2014 G.C. with Flame Ionization Detector and a manual injector. The method was validated for specificity, linearity, precision, accuracy, robustness, and solution stability. The specificity of the method was determined by stress testing of the drug (forced degradation). Response was a linear function of drug concentration in the range 2000-8000 μg/mL (r= 0.999). The LOD value for Magnesium Valproate was found to be 0.1 ppm and the LOQ value 1.0 ppm respectively. Accuracy (recovery) was between 99.54 and 100.28%. Same method is also well applicable for estimation of Sodium, Disodium, Calcium and Lithium salt of Valproic acid.

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تاریخ انتشار 2003