Abstract

The current USP procedure for the limit tests for 4-chloro-5-sulfamoyanthranilic acid (CSA) in furosemide preparations is a tedious and non-specific method. A simple, sensitive and specific method for the quantitative analysis of CSA from bulk materials and pharmaceutical preparations is described. The procedure consists of extraction into 0.1 N sodium hydroxide solution, dilution, addition of internal standard and injection onto a high-performance liquid Chromatograph. The eluate is monitored by ultraviolet absorption at 280 nm. Utilizing this procedure, CSA was quantitatively analyzed from furosemide tablets, furosemide injection and furosemide bulk powder.

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