Limit of free salicylic acid—
Mobile phase and Diluting solution—Prepare as directed in the Assay.
Standard solution— Dissolve an accurately weighed quantity of USP Salicylic Acid RS in the Standard preparation prepared as directed in the Assay, to obtain a solution having a known concentration of about 0.015 mg of salicylic acid per mL.
Test solution— Use the Stock solution prepared as directed for Assay preparation in the Assay.
Chromatographic system— Use the Chromatographic system described in the Assay. Chromatograph the Standard solution, and record the peak responses as directed for Procedure: the relative retention times are about 0.7 for salicylic acid and 1.0 for aspirin; the resolution, R, between salicylic acid and aspirin is not less than 2.0; and the relative standard deviation of the salicylic acid peak responses is not more than 4.0%.
Procedure— Proceed as directed for Procedure in the Assay. Calculate the percentage of salicylic acid (C7H6O3) in the portion of Tablets taken by the formula:
2000(C / QA)(rU / rS)
in which C is the concentration, in mg per mL, of USP Salicylic Acid RS in the Standard solution; QA is the quantity, in mg, of aspirin (C9H8O4) in the portion of Tablets taken, as determined in the Assay, and rU and rS are the peak responses of the salicylic acid peaks obtained from the Test solution and the Standard solution, respectively: not more than 0.3% is found. In the case of Tablets that are coated, not more than 3.0% is found.